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 |
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Breast Cancer Ovarian Cancer Uterine Cancer |
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 |
Estimated Study Start Date : | June 16, 2021 |
Estimated Primary Completion Date : | December 29, 2023 |
Estimated Study Completion Date : | December 29, 2023 |
Group/Cohort |
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Patient Relatives
Biological relatives (1st-3rd degree) of patients with histologically confirmed malignancy
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Patients
Patients with histologically confirmed malignancy
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patient or biological relative of a patient, as follows:
EXCLUSION CRITERIA:
- Pregnant subjects are eligible to take part; however, sample collection for those who are currently pregnant will only occur as follows:
Contact: Ann C McCoy, R.N. | (240) 760-6021 | ann.mccoy@nih.gov |
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) |
Tracking Information | |||||
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First Submitted Date | December 1, 2018 | ||||
First Posted Date | December 4, 2018 | ||||
Last Update Posted Date | June 11, 2021 | ||||
Estimated Study Start Date | June 16, 2021 | ||||
Estimated Primary Completion Date | December 29, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Establishment of a tissue repository for the collection and banking of tissue samples [ Time Frame: at study completion ] A tissue repository
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies | ||||
Official Title | Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies | ||||
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. |
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Detailed Description |
Background:
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. Eligibility:
Design:
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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 | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
500 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 29, 2023 | ||||
Estimated Primary Completion Date | December 29, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
EXCLUSION CRITERIA: - Pregnant subjects are eligible to take part; however, sample collection for those who are currently pregnant will only occur as follows:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03762733 | ||||
Other Study ID Numbers | 190025 19-C-0025 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) | ||||
Study Sponsor | National Cancer Institute (NCI) | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | September 15, 2020 |