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Enrolling By Invitation
NCT03762733
Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
Conditions: Breast Cancer, Ovarian Cancer, Uterine Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 500
Sponsor: National Cancer Institute (NCI)
Location: National Institutes of Health Clinical Center Bethesda Maryland
Summary
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.
Eligibility Criteria
* INCLUSION CRITERIA:
* Adult subject (age 18 and older) co-enrolled on a trial, or otherwise undergoing consultation, screening, or follow up on existing protocols conducted at the NIH Clinical Center, who are evaluated in the Women s Malignancies Branch Clinic.
* Participant or biological relative of a participant, as follows:
* Participant with a histologically confirmed breast cancer or other gynecologic malignancy; histopathology of the biopsy tissue must be
confirmed by the NCI Laboratory of Pathology, prior to banking of the tissue on this protocol.
* Biological relative (1st -3rd degree) of a participant who meets the eligibility of histologically confirmed malignancy per above
criterion.
* Subject willingness and ability to provide informed consent.
* Subject willingness to provide tissue samples for banking.
EXCLUSION CRITERIA:
\- Pregnant women are not eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).
Source: ClinicalTrials.gov (NCT03762733). StuddyBuddy aggregates publicly available trial information.