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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762733
Recruitment Status : Enrolling by invitation
First Posted : December 4, 2018
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Breast Cancer Ovarian Cancer Uterine Cancer

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
Actual Study Start Date : January 4, 2022
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : December 29, 2023


Group/Cohort
Patient Relatives
Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
Patients
Participants with histologically confirmed malignancy



Primary Outcome Measures :
  1. Establishment of a tissue repository for the collection and banking of tissue samples [ Time Frame: at study completion ]
    A tissue repository



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
  • 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.

EXCLUSION CRITERIA:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762733


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christina M Annunziata, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03762733    
Other Study ID Numbers: 190025
19-C-0025
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 18, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Biobanking
Tissue Repository
Genetic Analysis
Natural History
Additional relevant MeSH terms:
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Breast Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases