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 Relatives
    Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
  • Arm: Patients
    Participants 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)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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