Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 29, 2023 |
| Contact: | Rebecca S Trupp, R.N. |
| Email: | rebecca.trupp@nih.gov |
| Phone: | (240) 760-7533 |
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.
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.
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.
- 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.
- INCLUSION CRITERIA:
- Adult subject (age 18 and older)
- 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; however, sample collection for those who are
currently pregnant will only occur as follows:
- No samples will be drawn for biobanking from a pregnant subject.
- Primary treatment protocols exclude pregnant patients; therefore, no patient shall be
pregnant on this biorepository protocol, while they continue on the treatment
protocol; however, once the patient is no longer on the treatment protocol, there is
no restriction to pregnancy for this protocol; but, as per the above criterion, no
samples will be drawn for biobanking on a pregnant patient.
- Biological relatives of a patient may not be pregnant at the time of consent and
sampling; however, given that this is not a treatment protocol, there is no
restriction on pregnancy beyond the time of donation of the samples to be banked
(primarily blood for biological relatives)
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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