Search Results
SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOREARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)
The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery.This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.
We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. We are asking you to take part in this research study because you have early-stage oral cavity cancer and are having neck dissection surgery.
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.
Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA
Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.
The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
The purpose of this study is to test the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy)
•Blood collection for laboratory tests•CT/MRI/PET/CT scans•ECG•Take study drug•Tumor assessment
Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
Males or females, age ≥ 18 years
ECOG Performance Status/WHO Performance Status ≤ 1.
Life expectancy of > 24 months
Evidence of distant metastases at screening
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ
Presence of active infections
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY
this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.
Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
The Use of Micro-Doppler Radar to Identify Service Members at Risk for Musculoskeletal Injury: A Gold Standard Comparison
The purpose of this research study is to see if we can use micro-doppler signal technology to determine if someone has had an ACL reconstruction in the past. We will do this by comparing a group of people who have had the surgery against a group who has never had this surgery to see if this technology can tell the difference.
If you join this study you would be asked to come to a one-hour appointment at the Lebanon Valley College campus in Annville, PA and perform a variety of activities that are part of daily life, such as walking, jumping, and standing from a seated position. We'll ask you to complete a questionnaire on any musculoskeletal pain you're experiencing and report your demographic information.
50
ACL Group: ACL Reconstruction surgery 9-72 months prior and approved to return to normal activities
Control group: No history of lower extremity surgery
Able to provide consent and read/write in English
No current musculoskeletal injuries
Pregnant person
any surgery within 6 months of the study visit
Unable to provide consent or read/write in English
Unable to perform movements consistent with daily activities such as walking, jumping, or moving from sit to stand
EA8183 A Phase III Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE) (PSCI# 21-122)
This study is being done to answer the following question:Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
This study is being done to answer the following question:Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
Patient must have undergone a radical prostatectomy (RP) and must be preregistered to Step 0 of this study at least 6 weeks after but not more than 12 weeks after their radical prostatectomy.
Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer.
Patient must have an ECOG performance status of 0-2.
Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure).
EA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial (PSCI# 21-111)
The purpose of this study is to compare the usual treatment (surgery plus chemotherapy after) to using chemotherapy both before and after surgery. Receiving gemcitabine/cisplatin chemotherapy both before and after surgery could extend your life and prevent your cancer from returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will look to see if the chemotherapy increases the time to disease recurrence and if it increases a patient’s overall survival compared to the usual approach given both before and after surgery.
We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. We are asking you to take part in this research study because you have recently been diagnosed with gallbladder cancer that was found after your gallbladder was removed during surgery.
Patient must have an ECOG performance status of 0-1.
Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization
Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
Women must not be pregnant or breast feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
No radiographic evidence of distant disease (M1 disease)
No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)
No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes)
A PROSPECTIVE MULTICENTER STUDY TO ASSESS THE CLINICAL OUTCOMES OF CURRENT PHACOEMULSIFICATION APPROACH TO CATARACT EXTRACTION VERSUS THE MICOR SYSTEM DEVICE USING LOW ENERGY LENS EXTRACTION IN PATIENTS UNDERGOING CATARACT SURGERY
Research study to assess visual outcomes after cataract surgery between different devices. 3 trial groups open to males and females over the age of 18 who are to undergo cataract surgery.
There will be 3 in person visits per surgery eye.Vision will be checked at 2 of these visitsCataract surgery will be done at 1 of these visits
Must have a cataract that qualifies for surgery
Not Pregnant
Other eye conditions may not be allowed to participate, study coordinator will discuss further
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)
This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients withlocally advanced renal cell carcinoma randomly assigned toperioperative nivolumab in conjunction with radical or partialnephrectomy with patients randomized to surgery alone.
You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possiblesigns of recurrence (close observation)
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
PSCI 22-156 HCRN BRE17-141
The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.
Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial
This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
Patients will have to sign the consent form to participate in the trial
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study is to see if stool or blood can be used to determine whether or not a patient has any colon polyps or colon cancer. This study will compare these biological samples (blood, urine, stool) to any colonoscopy or surgery a patient has to see if the outcome could be predicted.
Subjects with Colon Cancer or Adenoma
OR subjects undergoing colonoscopy screening
HIV/Hepatitis
Have had or are receiving chemotherapy or radiation
Have had surgery for your colon cancer
Cognitive Impairment
PSCI 22-127 NRG-BN012: A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES
Individuals with cancer that has spread to their brain who have 1-4 lesions, or breast cancer history and may or may not have treatment and are within 8 weeks of surgery, will be randomized to either surgery first followed by radiation or radiation first followed by surgery.
Subjects are expected to come to all Radiation/Gamma Knife appointments and continue onto surgery/resection.
Known active or history of invasive non-CNSprimary cancer based on documented pathologic diagnosis within the past 3 years.
All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem.
Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
Age ≥ 18
Evidence of leptomeningeal disease
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
Inability to undergo MRI with contrast.
More than one brain metastasis planned for resection
A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resectionfor Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion inthe clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
PSCI# 24-028 NRG-BR008: A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO*)
This study will look at the differences in recurrence between patients who receive breast radiation after surgery to those who don't.
Participants will be required to come to all study visits, complete their radiation and chemotherapy treatments.
The patient must have an ECOG performance status of 0 ,1,
Histologically or cytologically confirmed invasive breast carcinoma.
The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.
patients with a primary tumor >2 cm on pathologic examination of the surgical specimen
Patient planning for or status-post mastectomy.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Multicentric carcinoma (invasive cancer or DCIS)
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase.In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia.Induction Treatment Phase (1-3 months)•Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase.Maintenance Treatment Phase (12 months)•Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor.Long-term Follow-up Phase (48 months)•Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.•Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)
This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
The study is conducted in 2 parts. Part 1 consists of a screening period, treatment period and a completion period including a period of long term follow up. During part 1, you will be asked to answer questions about your health, participate in a physical examination that includes vital signs,height and weight, have testing done including an electrocardiogram, blood draws, urine sampling, pregnancy test, biopsy, and medical imaging. Part 2 consists of an additional screening period, treatment period and an end of treatment period.
70.00 per visit
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial
Adults recently diagnosed with SARS-CoV-2 infection who use a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic® will have a reduced SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline. This combined intervention should be acceptable, tolerable and safe in this population. To test this, we are conducting a trial comparing the efficacy of a number of washes in reducing the oral and nasal SARS-CoV-2 viral load amongst adults.
At their home, participants will perform three nasal and oral rinses per day for 4 days and self-swab the nose and mouth before and after each morning rinse to collect specimens under the guidance of a zoom visit. On the morning of the 5th day participants will also self swab the nose and mouth for a final collection specimen. Participants will answer questions on an app and online platform.
100
A positive test for SARS-CoV-2 infection within 5 days of enrollment
Currently in isolation
Non-English speaking
Lack of electronic device (computer, mobile phone etc) on which to access an app for study data collection
Adults that need inpatient care for COVID-19 or any of its complications
Adults that give a history of being unable to tolerate gargles or nasal washes
Metabolic Alterations of the Semitendinosus Muscle After Tendon Harvest for Anterior Cruciate Ligament Reconstruction
This is a cohort study examining the changes in the muscle that occur following ACL injury and reconstruction. This study aims to determine if significant changes to the muscles properties occur as a result of the graft taken for ACL reconstruction, and whether or not these changes serve as a risk factor for further injuries. This study will examine the muscles ability to use oxygen non-invasively, an important determinant of muscle endurance and allow for comparisons of this between individuals with ACL-reconstruction surgery and healthy, non-injured adults.
Participants will have their leg muscle strength and endurance measured using common clinical techniques used in physical medicine and rehabilitation sciences. They will also have their mitochondrial capacity assessed through the skin using a non-invasive procedure.
$60.00
Full rehabilitation
autograft taken from hamstring tendon
other autografts may be considered
Recreationally active
BCC020: A Dose Escalation Study Using Difluoromethylornithine(DFMO) and AMXT-1501 followed by a Randomized Controlled Trial of DFMO with or without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas
The purpose of this study is to evaluate the investigational drug AMXT-1501 (a pill taken by mouth) in combination with the study drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.
PSCI 24-040 A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]
This protocol is comparing two types of surgery, one with the removal of the ovaries, fallopian tubes and uterus against removal of the fallopian tubes and uterus in subjects how are between 35 and 50 with the BRCA1 mutation..
Participants must be carriers of the BRCA1 gene mutation. This trial involves going to the operating room to have either their fallopian tubes removed or their ovaries and fallopian tubes removed. A vaginal ultrasound will be done. you will have blood drawn and a pregnancy test done. This will happen before surgery.
At least one intact ovary and fallopian tube
Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient.
Patients may be premenopausal or menopausal.
Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.
Prior history of ovarian cancer,
Patients medically unfit for the planned surgical procedure.
Patients with abnormal screening tests
A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Participants in the PIVOT-006 study will either receive surgical treatment plus cretostimogene or surgical treatment alone.This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by CG0070 vs TURBT for the treatment of patients with IR-NMIBC.The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for thecancer to return.Who May Be Eligible to Take Part In This Study:People with:• Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer) • Intermediate-Risk Disease • Over 18AllTreatment:18All patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period.Main Meausure:Patients who have recurrence of bladder cancer after receiving surgery plus cretostimogene compared to patients who receive surgery alone.
if you decide to take part in this study and meet all of the requirements, all patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. You will receive 6 treatments, once per week for 6 weeks in a row. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period. There will be up to 16 visits with blood draw and/or urine colelction. As a part of screening, efficacy and follow up for this study, you might have to have cystoscopy ( up to 6), urine cytology (up to 6), TUBRT or vladder mapping or CT urogram over a 3 year month period.
Intermediate-Risk Disease
Is ≥18 years of age on day of signing informed consent.
Demonstrates adequate organ function
Is willing to comply with study mandated cystoscopies, urine cytology, CT urograms, TURBTs/biopsies, and other procedures
Has disease that cannot be completely resected.
Has current or history of muscle-invasive cancer or locally advanced or metastatic bladder cancer
Has a history of High-grade or Low-Grade urothelial cancer
Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of randomization.
PSCI 23-110 CA209-6K6 An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer
We are asking you to take part in this voluntary research study because you have lung cancer that will require surgery, chemotherapy, and possibly immunotherapy. The study involves chemotherapy and immunotherapy given during the 6 weeks prior to surgery.
In person visits for Screening, Treatment and Follow-up visits. Treatment is given monthly on day 1,22 & 43. Special test will be conducted at these time periods such as Physical Exam, Blood Draws and CT/Pet scans.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.
Hemoglobin ≥ 9.0 g/dL
Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, with the exceptions of intranasal, inhaled, topical steroids
Patients with Grade ≥2 neuropathy
History of allogeneic organ transplant.
History of hypersensitivity to nivolumab or any excipient