Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 1, 2018

Keywords

ClinConnect Summary

This study is an observational project at the NIH Clinical Center that aims to build a large tissue bank for future cancer research. Researchers will collect and store samples such as blood, urine, and, if available, tumor tissue from adults with breast cancer or other gynecologic cancers (like ovarian or uterine cancer). They will also collect samples from biological relatives of these patients (first to third degree) who consent to participate. The goal is to help future scientists study DNA changes in cancer and support precision oncology, without testing a treatment in this study.

To be eligible, you must be 18 or older and either have a confirmed breast cancer or other gynecologic cancer, or be a biological relative of someone with cancer who meets the eligibility criteria. You must be willing to consent and to provide tissue for banking; pregnancy excludes participation. Participants may undergo a physical exam and answer questions about medical history and family history, and they will give blood and urine samples. Tumor tissue may be used if it’s already collected as part of your care. Tissue and related data may be shared with NIH researchers and, for genomic data, with dbGaP, to support future research. The study is not a treatment trial; it focuses on creating the tissue bank for future studies.

Gender

ALL

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 individuals are not eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).