Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03762733|
Recruitment Status : Enrolling by invitation
First Posted : December 4, 2018
Last Update Posted : March 23, 2023
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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 disease|
|Breast Cancer Ovarian Cancer Uterine Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
Participants with histologically confirmed malignancy
- Establishment of a tissue repository for the collection and banking of tissue samples [ Time Frame: at study completion ]A tissue repository
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.
|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|
- 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
- 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).
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
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christina M Annunziata, M.D.||National Cancer Institute (NCI)|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||December 4, 2018 Key Record Dates|
|Last Update Posted:||March 23, 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|
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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Site
Genital Neoplasms, Female