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

NCT03762733 | Enrolling By Invitation

• 2 other identifiers: 19002519-C-0025
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Uterine Cancer; Breast Cancer

Keywords

Biobanking; Tissue Repository; Genetic Analysis; Natural History

Outcome Measures

Primary Outcomes (1)

• Establishment of a tissue repository for the collection and banking of tissue samples

  A tissue repository

  at study completion

Study Arms (2)

Patient Relatives

Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy

Patients

Participants with histologically confirmed malignancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are being seen in follow up, consultation, or presenting for enrollment on a clinical trial at the NIH Clinical Center

You may qualify if:

• 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.

You may not qualify if:

• \- Pregnant women are not eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases

Study Officials

• Takeo Fujii, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 4, 2018
• Study Start: January 4, 2022
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-03-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)