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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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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Eligibility

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).


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jung-Min Lee, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 6B12
10 CENTER DR
BETHESDA MD 20892
(240) 760-6128
leej6@mail.nih.gov

Ann C. McCoy, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 82
Room 233
9030 Old Georgetown Road
Bethesda, Maryland 20892
(240) 760-6021
ann.mccoy@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03762733

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