Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT03762733
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
Background: A person s blood, tissue, and other samples contain DNA. Cancer is a disease of cells that are not working properly. It is caused by changes in DNA that build up. Researchers want to do future studies on DNA changes This may help them learn how to guide treatment for cancer. They need biological samples like tumors, blood, and urine for these studies. Objective: To create a place to collect and store biological samples from people with gynecologic malignancies like breast cancer. Samples from certain relatives of theirs will be collected too. Eligibility: Adults ages 18 and older who are being seen at NIH for breast cancer or other gynecologic malignancy Their biological relatives of the same age Design: Participants will answer questions about their family history. Participants will have a physical exam and medical history. This will include questions about age, ethnicity, and disease history. They will also answer questions about their medical treatments and responses. Participants will give blood and urine samples. Participants may give a tumor tissue sample. This will not be taken specifically for this study. It will be from a previous procedure or one that is already planned. Other samples may be taken only if a procedure is required for treatment. These include bone marrow, cerebrospinal fluid, and other fluids. A group of doctors and other professionals will oversee the sample storage place. The group will review all requests to be sure the use of the specimens is valid. ...
Key Dates
- Start date
- Jan 4, 2022
- Status verified
- Mar 2026
- Primary completion
- Dec 29, 2028
- Completion
- Dec 29, 2028
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: Patient RelativesBiological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
- Arm: PatientsParticipants with histologically confirmed malignancy
Primary Outcome Measure
Establishment of a tissue repository for the collection and banking of tissue samples [ Time Frame: at study completion ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | - |
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