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Clinical Trial 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.


Clinical Trial Description

Background:

- Increased understanding of the genomic variations of cancer through laboratory evaluations can result in breakthroughs in treatment and improved patient outcomes.

- Exceptional responders on clinical trials may have mutational characteristics that are unique and unknown, necessitating identification.

- Current drug development strategies employ precision oncology. This approach identifies molecular targets, with therapies being either chosen or developed to interact with the specific target.

- The collection and banking of a variety of tissue samples for future translational studies would support research and advance the mission of the NIH.

- Pleural effusions, ascites as well as other tissues, such as blood, CSF, tumor, bone marrow, and urine, provide a unique opportunity to conduct a variety of translational research, addressing many clinical questions.

- The establishment of a tissue repository would enhance the mission of the NCI, in helping to advance research supporting precision oncology.

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:

- Personal diagnosis of breast or other gynecologic malignancy, or be a 1st-3rd degree biological relative of a patient with cancer, currently or previously on a NIH clinical trial.

- All subjects (index patient with cancer and their 1st-3rd degree biological relatives) must sign consent and enroll onto this study, in order to donate tissue for biobanking on this protocol.

- Adults, greater than or equal to age 18, willing to provide tissue for biobanking

Design:

- Samples include, but not limited to tumor (e.g., tissue, outside parrafin blocks or slides), blood, serum, plasma, urine, bone marrow, cerebrospinal fluid (CSF), malignant ascites, and effusions; to be collected after subjects have met eligibility and signed consent. We will also obtain samples (mainly blood) from volunteer, consenting 1st-3rd degree biological relatives of patients with histologically confirmed cancer, to be paired with their family member.

- The following sample collection strategy is planned, other samples (if applicable) may be collected at the discretion of the PI:

- Ascites or pleural fluid: approximately 200cc-5L will be collected from patients undergoing therapeutic procedures.

- Peripheral blood: up to 30ml will be collected via either venipuncture or through existing intravenous access.

- Tumor tissue: a portion of the cores will be transferred to this study, and tracked via LabMatrix once clinical needs are met on the subject s main treatment protocol, and after subject signs consent. Biopsies will not be performed solely for the purpose of this study.

- Urine: (5-10 ml) obtained via clean catch method.

- Bone marrow: (1 core biopsy and half 1 ml of aspirate) obtained via routine sacral biopsy when clinically indicated.

- CSF: (1-2 ml) obtained via lumbar puncture when clinically indicated.

- Tissue will be accessed by study investigators. Additional CCR investigators who wish to use tissue from this repository must first provide a written Letter of Intent, (LOI), to be reviewed by an investigator appointed ad hoc committee for approval.

- Assays used for sample processing, establishment of cell lines, patient derived xenograft models, and storage are described in detail within this protocol. Also, some assays for future translational research are either listed or described herein. Further detailed description of experimental designs, along with statistical analysis, will be provided within future investigator-initiated sample use addendums to this protocol, or new IRB approved protocols, developed in order to study samples from this biorepository. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03762733
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact Irene Ekwede, R.N.
Phone (240) 760-6126
Email ekwedeib@mail.nih.gov
Status Not yet recruiting
Phase
Start date December 19, 2018
Completion date December 29, 2023

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