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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03762733|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : June 2, 2020
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|
|Estimated Study Start Date :||June 5, 2020|
|Estimated Primary Completion Date :||December 29, 2023|
|Estimated Study Completion Date :||December 29, 2023|
Biological relatives (1st-3rd degree) of patients with histologically confirmed malignancy
Patients 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
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
|Contact: Ann C McCoy, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Christina M Annunziata, M.D.||National Cancer Institute (NCI)|