This study is currently recruiting participants.
Number
19-C-0025
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Adults who are or may become unable to consent;Pregnant Women;Children
Keywords
Biobanking; Tissue Repository; Genetic Analysis; Natural History
Recruitment Keyword(s)
None
Condition(s)
Breast Cancer; Ovarian Cancer; Uterine Cancer
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
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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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 criterion. - Subject willingness and ability to provide informed consent. - Subject willingness to provide tissue samples for banking. EXCLUSION CRITERIA: - Pregnant individuals are not eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).
-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
criterion.
- Subject willingness and ability to provide informed consent.
- Subject willingness to provide tissue samples for banking.
EXCLUSION CRITERIA:
- Pregnant individuals are not eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).
Principal Investigator
Referral Contact
For more information: