Search Results
A prospective, observational cohort study to assess flares in participants with hidradenitis suppurativa
This is a questionnaire study to establish new ways to measure HS flares. Subjects and providers will each complete questionnaires at regularly occurring visits.
- Medical History and Demographics Review- Weekly Questionnaires- HS Skin Assessments
Up to $320
Active HS within 3 months of baseline
Reliable internet access on a phone or computer
Not fluent in English
Mental impairment that would prevent you from understanding and responding to questionnaires
A Review of the Carbon Labeling Landscape and Consumer Attitudes Towards Comparison Carbon Labeling Designs
A carbon label displays the carbon footprint of the product (a number, e.g., 1.18 kg CO2) and helps consumers understand the impact of the product on the environment. The purpose of this study is to understand Penn State students’ preferred method of carbon labeling for a senior thesis. The study will be conducted via a survey that takes less than 5 minutes and requires no personal identifying information.
The participants will complete one survey that takes less than 5 minutes to complete. The survey can be taken on a personal device or a Penn State computer.
Establishing the effect of flavor on the addictive potential of electronic cigarettes
For the current study, nicotine users will use an electronic cigarette in addition to their usual nicotine source for 4 weeks. The electronic cigarette will contain sweet or tobacco flavored liquid that may or may not contain nicotine. Participants will complete functional magnetic resonance imaging scans at the beginning and end of the study to measure how the brain responds to the electronic cigarette flavor.
There will be two remote visits and two in person visits. There will be a MRI during each in person visit and the subject will be given an study electronic cigarette to use between the two MRI visits.
220
Nicotine Useres
Not currently interested in quitting smoking
Pregnant or nursing
Implanted metal in the body
The Effects of Aircraft Seat Width on Passenger Comfort
The objective of this research is to determine the relationship between aircraft seat width and passenger comfort. Airlines are reducing the sizes of seats and improving their ability to fly planes at or near capacity. The combined effect is to decrease the quality of the experience of passengers. This work will help us to understand the degree to which comfort has been reduced.
You must be a healthy adult aged 18 years or older.
COVID-19 and microvascular function
This study will investigate the link between previous COVID-19 infection and future heart disease risk.
HAD COVID-19
DID NOT HAVE COVID-19
Non-Obese
Non-Smoker
Pregnant and/or breastfeeding
Taking blood pressure medication
Randomized Phase III Trial of MEDI4736 (durvalumab) asConcurrent and Consolidative Therapy or ConsolidativeTherapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041).
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
Centre County COVID-19 Data 4 Action Study
The purpose of this research is to evaluate the extent of COVID-19 risk and perceived risk among Centre County residents and students, and how those risks evolve from the time isolation guidelines were implemented through a return to normal functioning.Participants in this research will complete an electronic survey with questions about their demographic, about their exposure to COVID-19, and about how COVID-19 has affected their health and work/education. Data from this research will be used to inform Centre County planning authorities and the Pennsylvania State University about the needs of communities, including needs for information dissemination and for potentially actionable, local interventions in response to the COVID-19 pandemic.
Currently living in Centre County, PA.
Expect to continue living in Centre County, PA (through at least Sept 2020)
Capable of providing your own informed consent.
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.
Multimodal brain MRI-guided understanding of non-motor outcomes in Parkinson's post DBS
This study will explore the relationship between multimodal brain MRI findings and cognitive/mood outcomes in Parkinson's Disease (PD) patients following Deep Brain Stimulation (DBS). Patients already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS to collect motor, neurobehavioral and physical therapy measurements.
Patients who are already planning to undergo DBS for PD who choose to take part in this study will have study visits before and after DBS surgery to collect motor, neurobehavioral and physical therapy measurements. While many of these components are part of as standard of care, some assessments will need to be collected specifically for research purposes. There are two in-person visits (one before DBS surgery and one approximately 3-6 months after surgery). As part of the study, an MRI to gather data to answer our research questions will be conducted. This is in addition to the clinical MRI that is part of the regular assessment to determine if an individual is suitable for the DBS surgery.
$130 if components of study are completed
Diagnosed with Parkinson's Disease
Undergoing DBS as part of standard of care
Able to provide informed consent
General contraindications to surgery
Pregnant or nursing women
Unable to undergo MRI for any reason
Atypical Parkinsonism
A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA (PSCI# 20-016) (EA3161)
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it 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 be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
Interlimb differences in Motor Control and Learning
This study examines how each brain hemisphere contributes to motor control and coordination. Participants play virtual reality/computer games to look at how their arms move during different activities.
upper-extremity orthopedic injuries that interfere with participation
An Open Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in patients with B-Cell Non-Hodgkin Lymphoma(GO40516)(PSCI18-058)
This is a drug study that will compare drug mosunetuzumab with drug polatuzumab vedotin in patients with non-Hodgkin lymphoma (NHL).
This study has three parts:1. Screening (to see if you are eligible for the study)2. Treatment3. Follow-up (to check on you after treatment is finished)If you are enrolled in the FL or DLBCL cohort during the single-arm expansion phase, you will receive mosunetuzumab for 8-17 cycles and polatuzumab vedotin for 6 cycles, with each cycle lasting 21 days.In addition to the single-arm expansion phase, the study may open another expansion phase of the study for the DLBCL cohort. If you are enrolled in the additional DLBCL expansion phase, you will be randomly assigned to one of three possible arms. Neither you nor your study doctor may choosethe arm you will be in.- Mosunetuzumab in combination with polatuzumab vedotin- Mosunetuzumab alone- Bendamustine plus rituximab in combination with polatuzumab vedotinAfter your last dose, your study doctor will follow up with you about every 3 months for approximately2 years or longer (as long as you agree to it). Your total time in the study (Phase II expansion portion)will depend on how your DLBCL, FL, or MCL responds to treatment. This could range from 1 dayto more than 2 1/2 years.
Life expectancy of at least 12 weeks
Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
Adverse events from prior anti-cancer therapy resolved to < or = Grade 1
Hepatic Function: < or =AST and ALT < or = 2.5 x ULN; total bilirubin < or = 1.5 x ULN
Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
Prior treatment with polatuzumab vedotin
Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 4 weeks before first dose of study treatment
Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
Prevalence of Avoidant Restrictive Food Intake Disorder (ARFID) traits among children and adolescents with Food Allergy
This study looks at understanding eating behaviors and attitudes toward food in children/adolescents. More specifically the study's goal is to compare those with and without food allergies to gain a better understanding of a possible underlying factor towards certain behaviors. Children and their caregivers will complete a survey composed of a short section on the child's medical history regarding allergies followed with questions in commonly used clinical assessments.
Age 18 years or older
Intellectual disability preventing comprehension of questions
Child and/or caregiver unable to respond to English-language questionnaire
Multidisciplinary Collaboration as a Bridge to the Ethical Collection of Patient-level Data on Social Determinants of Health (SDoH)
The purpose of this study is to create a tool that will evaluate a patients social determinants of health, which is the environment in which someone is born, works and lives. This tool could provide information to physicians that could help the patient avoid negative health outcomes.
Patient at Penn State Health OR Community Member
Can read and write in English
prisoner
Brain Injury
Women, Opioid Use Disorder, and Criminal Justice: A Qualitative Study
Opioid-related overdose deaths and incarceration rates have skyrocketed and have disproportionately affected women. Despite having a higher burden of substance use disorders and HIV/AIDS than criminal justice-involved (CJI) men, CJI women are less likely to have access to substance use and HIV treatment. This qualitative study will conduct in-depth interviews with CJI women, MAT providers, and criminal justice professionals to identify facilitators and barriers to illicit opioid use cessation and related issues among CJI women.
substance use
opioid use
criminal justice
drug treatment
Applying Social cognitive theories of learning to Adaptive Learning
In this work, we wish to explore how social learning can be promoted in the case of adaptive learning.
Human-AI Interaction
We are conducting a series of focus groups to examine why people use technologies driven by artificial intelligence, and what gratifications people gain from those interactions. This is part of a larger project to understand human-AI interaction (HAII), a relatively new concept in the field of human-computer interaction. Our goal is to help pioneer a definition of HAII by first understanding the basics of how and why people use AI-driven technologies. Focus groups will consist of 5-10 people and will take no more than one hour to complete. All consenting adults near the State College area are welcome to participate.
Able to participate in-person in State College
Willing to discuss technology habits in a group setting
Unable to attend in-person focus groups
Communicating Queer Chinese Identities: A Qualitative Investigation of the Visibility and Intelligibility of Transnational Queer Women in the United States
In today’s climate of anti-Asian hate, we believe that it is important to uncover different aspects of what “being Chinese” could look like. To this end, we are looking for individuals who self-identify as ethnically Chinese, woman, and a member of the LGBTQIA+ community to participate in a one-time 90-minute online interview to learn about what they do in their regular, everyday life to try to show or tell others about who they are. As part of the study, we will ask interviewees to share some visual images (e.g., photos, drawings, etc.) that they own as a way of elaborating on the ways that they communicate their self-identity in everyday life.
Chinese ethnicity
Woman
Non-woman
Not Chinese ethnicity
20-081, Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combo with Axitinib in Advanced RCC
Determine the maximum tolerated dose or maximum administered dose of MEDI5752 combined with axitinibAssess the safety and tolerability of MEDI5752 combined with axitinibAssess the antitumor activity of MEDI5752 combined with axitinib
The study will consist of 3 periods: screening, study treatment, and follow-up. You are expected to keep all of your study appointments and complete all study procedures.
$75 Per visit
Histologically or cytologically proven advanced RCC
Advanced RCC not previously treated in that setting
Must have at least 1 measurable lesion according to RECIST v1.1
Life expectancy ≥ 12 weeks
Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC
History of active primary immunodeficiency
History of organ transplant
PSCI 21-176 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute MyeloidLeukemia Who Are Ineligible for Intensive Chemotherapy
The purpose of this study is to see if magrolimab in combination with venetoclax and azacitidine is more effective than venetoclax and azacitidine in participants newly diagnosed with AML that are unfit for intensive chemotherapy.
Participants will be required to provide medical history, complete physical exam, laboratory tests, bone marrow biopsy and aspirate, ECOG, ECG, Echo or MUGA, pulmonary function tests, questionnaires, take study drug
ECOG performance status: a) Of 0 to 2 for subjects ≥ 75 years of age Or b) Of 0 to 3 for subjects ≥ 18 to 74 years of age
Patients with white blood cell (WBC) count ≤ 20 103/μL prior to randomization.
Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment.
Patient has provided informed consent
Breastfeeding female
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
Patients receiving any live virus vaccine within 4 weeks prior to initiation of study treatments
Prior treatment with any of the following: a) CD47 or SIRPα-targeting agents
Public Perception of Public Health Wireless Emergency Alerts
The objectives of this study are to understand attitudes, emotional response, and behavioral intention related to receiving COVID-19 public health messaging via the Wireless Emergency Alert system.
Received a Wireless Emergency Alert in November
Did not receive a Wireless Emergency Alert in November
Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Development of AI-Trust Model in Electronic Finances
The purpose of this study is to create a model that can predict a quantifiable change in human trust based on the performance of artificial intelligence. This is done through a 30 turn financial simulation where participants must invest "money" in stocks while being given the option to use or not use the assistance of an artificial intelligence.
18 years of age or older
Access to a computer
17 years of age or younger
No access to a computer
VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment
Site For VIOLET
shock
sepsis
pancreatitis
Vit. D deficiency
blood Calcium levels > 10.2
known kidney stone in past 1 year
Do Not Rescusitate orders (DNR)
prisoner
CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors (ELVCAP-001-01)(20-095)
Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
Most of the examinations, tests and procedures are part of the usual approach for your cancer. However, there will be extra procedures like blood draws and additional tests on your tumor to determine if your condition is suitable to take part in this study.There are three stages to this study: Screening, Study Treatment period, End of Study Treatment/Follow-up.
Availability of fresh or archived tumor sample
Minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies
ECOG performance status 0, 1 or 2
At least one measurable extra-cranial lesion
Life expectancy < 3 months
Pregnant or lactating
Symptomatic or untreated brain metastases
Known hypersensitivity to any of the components of seribantumab
What’s in a grammar? A microcomparative study of negation in American Englishes
In contexts where people speak different dialects of the same language, how much overlap is there between the dialects, and what are the genuine grammatical differences? This study explores this question through a series of three experiments examining how people from three different dialects understand a variety of negative sentences (e.g., I didn't eat nothing). The results will contribute to our understanding of linguistic diversity.
Participants will sit at a computer and have their eye movements tracked by a camera as they read or listen to sentences and look at pictures on the screen.
$15 per hour
not 18 or older
Pilot evaluation of a multisensory evoked potential brain-computer interface
A brain-computer interface (BCI) is a device that has the potential to restore communication by translating voluntarily controlled brain signals of intent. The P300 speller, a popular BCI paradigm, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. This evoked potential is used to control a spelling interface. Those with advanced ALS experiencing the loss of voluntary muscular control may also experience cognitive changes that result in decreased capacity for BCI control using the P300 speller.With this pilot study, we aim to validate the performance of a combination of eye tracking and standard sensory testing to quantify intact sensory and cognitive processes necessary for the generation of a P300 response. Additionally, we will evaluate the association of these correlates with performance on a multisensor P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli. The goal is to demonstrate the viability of this system for future use in a patient group.
A brain-computer interface (BCI) is a device that has the potential to restore communication by direct translation of brain signals into computer commands. The BCI used in this study, the P300 Speller, relies on the generation of a P300 evoked potential when a user is presented a rare and unpredictable target stimulus amidst a larger pool of non-target stimuli. During this 2-hour, single session study, we aim to use a combination of eye tracking and sensory testing to quantify sensory and cognitive processes necessary for the generation of a P300 response. We will test the performance of a multisensory P300 spelling task, where brain potentials are evoked using a combination of visual, auditory, and tactile stimuli.
Fluent in written and spoken English.
History of seizure disorder
Co-existing neurological or psychiatric illness that, in the opinion of the research team, exclude the subject from participation.
PSCI 22-124 MAIN-CAV: PHASE III RANDOMIZED TRIAL OF MAINTENANCE CABOZANTINIB AND AVELUMAB VS MAINTENANCE AVELUMAB AFTER FIRST-LINE PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH METASTATIC UROTHELIAL CANCER
To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.
Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years
No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse. This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse.This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
P16-positive based on local site immunohistochemical tissue staining
Zubrod Performance Status of 0-1 within 14 days prior to registration
Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Recurrent disease
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
Mechanisms of Cardiovascular Disease (MCD)
The primary objective of this protocol, Mechanisms of Cardiovascular Disease (MCD) is to collect biological specimens and data from patients with cardiovascular disease (CVD) to study the mechanisms that contribute to cardiovascular dysfunction and disease.
If you decide to participate in this study, you will be asked to provide a blood sample and possibly additional optional samples, either immediately or later. Additional samples may include saliva, cheek swab, urine, waste tissue or nasal swabs. You will decide whether you are willing to provide these other samples. Clinical data will be included in the dataset along with your sample.
children less than 18 years with or without cardiovascular disease
Adult participants who are unable to provide a biologic sample