Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • Ovarian Cancer
  • Uterine Cancer
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 iden...

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.

Tracking Information

NCT #
NCT03762733
Collaborators
Not Provided
Investigators
Principal Investigator: Christina M Annunziata, M.D. National Cancer Institute (NCI)