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4 Study Matches

PSCI 23-099 NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancerand an Oncotype Recurrence Score ≤ 25 (OFSET)

To determine if chemotherapy added to ovarian suppression and endocrine therapy is better than endocrine therapy and ovarian supression alone.

Subjects will be required to keep all study appointments, take the medications as required, have an annual mammogram, inform the study of any over the counter medications they may be taking.

Yes
 

Monali Vasekar
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05879926
STUDY00023629
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Inclusion Criteria:
Female patients must be ≥ 18 years of age.
Patients must be premenopausal
The patient must have an ECOG performance status of ≤ 2
Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease.
pT4 tumors, including inflammatory breast cancer.
History of ipsilateral or contralateral invasive breast cancer.
Life expectancy of < 10 years due to co-morbid conditions in the opinion of the investigator.
Cancer
Approved drug(s)
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Hershey, PA ,

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.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04251052
STUDY00025098
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Inclusion Criteria:
Individuals 35-50 years of age, inclusive.
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.

Exclusion Criteria:
Individuals with a history of any prior cancer
Prior history of ovarian cancer,
Patients medically unfit for the planned surgical procedure.
Patients with abnormal screening tests
Cancer
Not applicable
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Hershey, PA ,

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women with Infertility Due to Polycystic Ovary Syndrome

This is a randomized trial whereby a study device will be used to remove tissue from the ovary via a transvaginal ultrasound procedure in order to promote/restore ovulation in women with infertility due to PCOS. Weekly serum blood draws will also be obtained to determine ovulation rates during the first 12 weeks of study enrollment. Those randomized to the control arm will have the option of crossing over to the device arm after 3 months.

Preliminary visit to assess eligibility followed by randomization into the Device or Control Arm. Device Arm requires May Health procedure (approximately 1 hour long, similar to ovarian drilling) followed by 12 weekly blood tests and 6 follow up clinic visits and follow up calls for up to 36 months after the procedur4e. Control Arm requires 12 weekly blood tests and the option to cross-over to the device arm after 3 months. If no cross-over occurs, the control arm will have one follow up visit at 3 months and can then exit the study. Both arms will complete questionnaires and log menstruation dates in an e-diary.

1220

Yes
 

Stephanie Estes
Robinn Moyer - at rmoyer3@pennstatehealth.psu.edu or 717-531-6272
Medicine: Endocrinology, Diabetes and Metabolism (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06206746
STUDY00023415
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Inclusion Criteria:
18-40 years of age
Infertility associated with oligo or anovulation and ultrsonographic evidence of PCOS or evidence of hyperandrogenemia
At least one ovary with volume greater or equal to 10.0ml
Ovarian accessibility by transvaginal ultrasound transducer
Has not responded to first-line ovulation induction treatment

Exclusion Criteria:
Currently pregnant
BMI greater than 40
Marked hyperandrogenism
Poor glycemic level control (greater than 6.5%)
Bleeding disorders
Women's Health
Experimental device
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Hershey, PA ,

PSCI #24-133 A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator’s Choice (IC) in Patients with Platinum Resistant Ovarian Cancer

this trial will see if using Rina S is better in treating ovarian cancer than standard treatment.,

Participants will need to come in for all study visits, take the medication as instructed, report all side effects and all medications including over the counter ones to the study team.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06619236
STUDY00026778
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Inclusion Criteria:
Be at least 18 years of age
must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Patients must have received 1 to 4 prior lines of therapy.

Exclusion Criteria:
Have primary platinum-refractory disease
Known active central nervous system metastases or carcinomatous meningitis
Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,