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

• ClinicalTrials.gov Identifier: NCT03762733
• Recruitment Status: Enrolling by invitation
• First Posted: December 4, 2018
• Last Update Posted: January 20, 2023
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information

• First Submitted Date: December 1, 2018
• First Posted Date: December 4, 2018
• Last Update Posted Date: January 20, 2023
• Actual Study Start Date: January 4, 2022
• Estimated Primary Completion Date: December 29, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 1, 2018)

Establishment of a tissue repository for the collection and banking of tissue samples [ Time Frame: at study completion ]

A tissue repository

• Original Primary Outcome Measures: Same as current
• 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.

Detailed 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, >= age 18, willing to provide tissue for biobanking

Design:

Samples include, but are not limited to, tumor (e.g., tissue, outside paraffin blocks or slides), blood, serum, plasma, and urine; to be collected after subjects have met eligibility and signed consent. Clinically-indicated samples (e.g., bone marrow, cerebrospinal fluid (CSF), malignant ascites, and effusions) collected under treatment protocols may be transferred to this biorepository protocol for research 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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• 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

• Breast Cancer
• Ovarian Cancer
• Uterine Cancer

• Intervention: Not Provided

Study Groups/Cohorts

• Patient Relatives
  Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
• Patients
  Participants with histologically confirmed malignancy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: December 1, 2018): 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

• 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.

• Patient or biological relative of a patient, as follows:

  • Patient 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 patient who meets the eligibility of histologically confirmed malignancy per above criterion.
• Subject willingness and ability to provide informed consent.
• Subject willingness and ability to provide tissue samples for banking.

EXCLUSION CRITERIA:

- Pregnant subjects are eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03762733
• Other Study ID Numbers: 190025; 19-C-0025
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
• Original Responsible Party: Same as current
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christina M Annunziata, M.D.; National Cancer Institute (NCI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: January 18, 2023