Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | Any - 99 |
| Updated: | 3/8/2019 |
| Start Date: | May 1, 2019 |
| End Date: | August 1, 2035 |
| Contact: | Javed Khan, M.D. |
| Email: | khanjav@mail.nih.gov |
| Phone: | (301) 435-2937 |
Clinical Sequencing of Cancer and Tissue Repository: ClinOmics
Background:
Saliva, blood, tissue, and cancer contain DNA. DNA makes the "instruction book" for the cells
in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want
to test DNA of people with tumors. They want to look for genetic changes in tumors that could
be targets for treatment. Because DNA can change as cancer changes, more testing may be done
at different times.
Objectives:
To find the DNA changes in cancer that may help guide treatment. To collect samples and data
to be used in future studies.
Eligibility:
People any age with cancer or a pre-cancerous tumor
Design:
- Participants will be screened with a medical history, physical exam, and blood tests.
Participants will give a sample of their tumor. This is usually from a previous
procedure. Participants will give a saliva or blood sample. They cannot eat, drink,
smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon
of saliva into a tube.
- Some participants may have a punch biopsy instead. A small instrument will take a small
piece of skin.
- Researchers will collect data from participants medical records.
- Participants will answer questions about their family health history. They will also
answer questions about their views on the study, including possible unexpected results.
- Extra blood or tissue samples may be taken at other times during the participants'
treatment. All samples will be saved in secure ClinOmics freezers to be used in future
studies.
- Participants will be told by their doctors if any test results affect their health or
their cancer treatment.
Saliva, blood, tissue, and cancer contain DNA. DNA makes the "instruction book" for the cells
in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want
to test DNA of people with tumors. They want to look for genetic changes in tumors that could
be targets for treatment. Because DNA can change as cancer changes, more testing may be done
at different times.
Objectives:
To find the DNA changes in cancer that may help guide treatment. To collect samples and data
to be used in future studies.
Eligibility:
People any age with cancer or a pre-cancerous tumor
Design:
- Participants will be screened with a medical history, physical exam, and blood tests.
Participants will give a sample of their tumor. This is usually from a previous
procedure. Participants will give a saliva or blood sample. They cannot eat, drink,
smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon
of saliva into a tube.
- Some participants may have a punch biopsy instead. A small instrument will take a small
piece of skin.
- Researchers will collect data from participants medical records.
- Participants will answer questions about their family health history. They will also
answer questions about their views on the study, including possible unexpected results.
- Extra blood or tissue samples may be taken at other times during the participants'
treatment. All samples will be saved in secure ClinOmics freezers to be used in future
studies.
- Participants will be told by their doctors if any test results affect their health or
their cancer treatment.
Background:
- Laboratory-based investigations have contributed to an improved understanding of the
biology of cancer and to the development of new therapies for malignancies.
- Omics investigation may identify novel drivers in the germline or tumor for high risk,
relapsed, refractory or rare cancers.
- Omics investigation may identify germline or somatic alterations that are medically
actionable and or can enable precision therapy.
Objectives - Primary Objective:
-Identify incidental and secondary findings in germline DNA and actionable somatic mutations
for reporting clinical results from a CLIA-certified lab into CRIS medical records.
Eligibility - Adult or Pediatric patients of any age with one of the following:
- Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer
susceptibility familial syndromes, regardless of patient age; OR
- Individuals without history of malignancy who are undergoing surgery; OR
- Individuals without a history of cancer but evidence of an inherited cancer syndrome
based on family history and/or other manifestations of a pre-cancerous syndrome (e.g.
polyposis, plexiform neurofibromas, myelodysplastic disease); OR
- Patient enrolled in an approved companion protocol.
- Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
that has been previously collected under CLIA and maintained in a CLIA lab which is
available for CLIA analysis.
- Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
that has been previously collected and is available for research analysis.
- Biospecimens can be collected with minimal additional risk to the subject during
sampling or procedures required for routine patient care.
- Individual may be undergoing treatment for malignancy, premalignant condition or
receiving other care associated with an inherited cancer syndrome.
- Patients may be referred to the Principal Investigator from outside institutions.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent OR
- IRB waiver of the requirement for informed consent for specific types of tissue.
Design:
- This study will allow for the collection of specimens for CLIA reporting of germline and
somatic mutations. The study will also collect specimens for a Tissue Repository, and
for other investigations as outlined below.
- CLIA testing activities will include
- DNA extracted from a section of tumor, malignant tissue, blood, or bone marrow
samples for somatic mutation sequence analysis
- Germline DNA extracted from lymphocytes, saliva, skin, or any normal uninvolved
tissues for sequence analysis to identify somatic alterations in the cancer and for
the reporting of incidental findings of established clinical validity and utility.
- Research activities may include:
- DNA, RNA and protein Omics analyses from extracted normal and/or tumor tissues; the
remainder of the tumor tissue will be stored.
- Germline DNA and RNA analyses from extracted lymphocytes or other normal uninvolved
tissue.
- T (TCR) or B Cell Receptor sequencing from blood, tumor, or malignant tissue.
- Establishing Patient-Derived Models such as patient-derived xenografts (PDXs),
early-passage in vitro tumor cultures, and organoid cultures, conditionally
reprogrammed cells (CRC) lines, explant and cell lines from tumor or normal samples
by the NCI Patient-Derived Models Repository (PDMR) at Frederick National
Laboratory for Cancer Research or by the OncoGenomics laboratory.
- Cryopreservation of viable normal (e.g. PBMC) or malignant tissues.
- Establishment of EBV transformed cell lines from blood for medical research either
by Coriell Institute or by investigators on this protocol.
- Omics (Genomics, Proteomic, Epigenetics, Metabolomics) studies will be performed.
- Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.
- Laboratory-based investigations have contributed to an improved understanding of the
biology of cancer and to the development of new therapies for malignancies.
- Omics investigation may identify novel drivers in the germline or tumor for high risk,
relapsed, refractory or rare cancers.
- Omics investigation may identify germline or somatic alterations that are medically
actionable and or can enable precision therapy.
Objectives - Primary Objective:
-Identify incidental and secondary findings in germline DNA and actionable somatic mutations
for reporting clinical results from a CLIA-certified lab into CRIS medical records.
Eligibility - Adult or Pediatric patients of any age with one of the following:
- Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer
susceptibility familial syndromes, regardless of patient age; OR
- Individuals without history of malignancy who are undergoing surgery; OR
- Individuals without a history of cancer but evidence of an inherited cancer syndrome
based on family history and/or other manifestations of a pre-cancerous syndrome (e.g.
polyposis, plexiform neurofibromas, myelodysplastic disease); OR
- Patient enrolled in an approved companion protocol.
- Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
that has been previously collected under CLIA and maintained in a CLIA lab which is
available for CLIA analysis.
- Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
that has been previously collected and is available for research analysis.
- Biospecimens can be collected with minimal additional risk to the subject during
sampling or procedures required for routine patient care.
- Individual may be undergoing treatment for malignancy, premalignant condition or
receiving other care associated with an inherited cancer syndrome.
- Patients may be referred to the Principal Investigator from outside institutions.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent OR
- IRB waiver of the requirement for informed consent for specific types of tissue.
Design:
- This study will allow for the collection of specimens for CLIA reporting of germline and
somatic mutations. The study will also collect specimens for a Tissue Repository, and
for other investigations as outlined below.
- CLIA testing activities will include
- DNA extracted from a section of tumor, malignant tissue, blood, or bone marrow
samples for somatic mutation sequence analysis
- Germline DNA extracted from lymphocytes, saliva, skin, or any normal uninvolved
tissues for sequence analysis to identify somatic alterations in the cancer and for
the reporting of incidental findings of established clinical validity and utility.
- Research activities may include:
- DNA, RNA and protein Omics analyses from extracted normal and/or tumor tissues; the
remainder of the tumor tissue will be stored.
- Germline DNA and RNA analyses from extracted lymphocytes or other normal uninvolved
tissue.
- T (TCR) or B Cell Receptor sequencing from blood, tumor, or malignant tissue.
- Establishing Patient-Derived Models such as patient-derived xenografts (PDXs),
early-passage in vitro tumor cultures, and organoid cultures, conditionally
reprogrammed cells (CRC) lines, explant and cell lines from tumor or normal samples
by the NCI Patient-Derived Models Repository (PDMR) at Frederick National
Laboratory for Cancer Research or by the OncoGenomics laboratory.
- Cryopreservation of viable normal (e.g. PBMC) or malignant tissues.
- Establishment of EBV transformed cell lines from blood for medical research either
by Coriell Institute or by investigators on this protocol.
- Omics (Genomics, Proteomic, Epigenetics, Metabolomics) studies will be performed.
- Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.
- INCLUSION CRITERIA:
Adult or Pediatric patients with one of the following:
- Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer
susceptibility familial syndromes, regardless of patient age; OR
- Individuals without history of malignancy who are undergoing surgery; OR
- Individuals without a history of cancer but evidence of an inherited cancer syndrome
based on family history and/or other manifestations of the syndrome (i.e. polyposis,
plexiform neurofibromas, myelodysplastic syndrome); OR
- Tissue (including tumor, normal, blood, serum, plasma, or other tissues) that has been
previously collected under CLIA and maintained in a CLIA lab which is available for
CLIA analysis.
- Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
that has been previously collected and is available for research analysis.
- Biospecimens can be collected with minimal additional risk to the subject during
sampling or procedures required for routine patient care.
- Individual may be undergoing treatment for malignancy, premalignant condition or
receiving other care associated with an inherited cancer syndrome.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent; OR
- IRB waiver of the requirement for informed consent for specific types of tissue.
EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 844-436-0642
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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