Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03762733 |
| Other study ID # |
190025 |
| Secondary ID |
19-C-0025 |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2022 |
| Est. completion date |
December 29, 2028 |
Study information
| Verified date |
June 6, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
