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

National Cancer Institute (NCI) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
Anticipated Duration (Months)
Patients Per Site Per Month

Study Details

Study Description

Brief Summary


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.


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.


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


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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description


    Increased understanding of the genomic variations of cancer through laboratory evaluations can result in breakthroughs in treatment and improved patient outcomes.

    Exceptional responders on clinical trials may have mutational characteristics that are unique and unknown, necessitating identification.

    Current drug development strategies employ precision oncology. This approach identifies molecular targets, with therapies being either chosen or developed to interact with the specific target.

    The collection and banking of a variety of tissue samples for future translational studies would support research and advance the mission of the NIH.

    Pleural effusions, ascites as well as other tissues, such as blood, CSF, tumor, bone marrow, and urine, provide a unique opportunity to conduct a variety of translational research, addressing many clinical questions.

    The establishment of a tissue repository would enhance the mission of the NCI, in helping to advance research supporting precision oncology.

    Primary Objective:

    To establish a tissue repository for the collection and banking of tissue samples from patients with breast and/or other gynecologic malignancies, as well as patients consenting 1st -3rd degree biological relatives, seen at the NIH for support of future translational research conducted at the NIH.


    Personal diagnosis of breast or other gynecologic malignancy, or be a 1st-3rd degree biological relative of a patient with cancer, currently or previously on a NIH clinical trial.

    All subjects (index patient with cancer and their 1st-3rd degree biological relatives) must sign consent and enroll onto this study, in order to donate tissue for biobanking on this protocol.

    Adults, >= age 18, willing to provide tissue for biobanking


    Samples include, but are not limited to, tumor (e.g., tissue, outside paraffin blocks or slides), blood, serum, plasma, and urine; to be collected after subjects have met eligibility and signed consent. Clinically-indicated samples (e.g., bone marrow, cerebrospinal fluid (CSF), malignant ascites, and effusions) collected under treatment protocols may be transferred to this biorepository protocol for research We will also obtain samples (mainly blood) from volunteer, consenting 1st-3rd degree biological relatives of patients with histologically confirmed cancer, to be paired with their family member.

    Tissue will be accessed by study investigators. Additional CCR investigators who wish to use tissue from this repository must first provide a written Letter of Intent, (LOI), to be reviewed by an investigator appointed ad hoc committee for approval.

    Assays used for sample processing, establishment of cell lines, patient derived xenograft models, and storage are described in detail within this protocol. Also, some assays for future translational research are either listed or described herein. Further detailed description of experimental designs, along with statistical analysis, will be provided within future investigator-initiated sample use addendums to this protocol, or new IRB approved protocols, developed in order to study samples from this biorepository.

    Study Design

    Study Type:
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
    Anticipated Study Start Date :
    Oct 20, 2021
    Anticipated Primary Completion Date :
    Dec 29, 2023
    Anticipated Study Completion Date :
    Dec 29, 2023

    Arms and Interventions

    Patient Relatives

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


    Participants with histologically confirmed malignancy

    Outcome Measures

    Primary Outcome Measures

    1. Establishment of a tissue repository for the collection and banking of tissue samples [at study completion]

      A tissue repository

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:

    • 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.

    • Patient or biological relative of a patient, as follows:

    • Patient 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 patient who meets the eligibility of histologically confirmed malignancy per above criterion.

    • Subject willingness and ability to provide informed consent.

    • Subject willingness and ability to provide tissue samples for banking.

    • Pregnant subjects are eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).

    Contacts and Locations


    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)


    • Principal Investigator: Christina M Annunziata, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 190025
    • 19-C-0025
    First Posted:
    Dec 4, 2018
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Sep 24, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by National Cancer Institute (NCI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021