Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

study id #: NCT03027401

condition: Neoplasms, Adenomatous Polyposis Coli, Neurofibroma Plexiform, Myelodysplastic Syndromes

status: not yet recruiting

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.

start date: May 1, 2019

estimated completion: August 1, 2035

last updated: March 6, 2019

size / enrollment: 5000

study design: Time Perspective: Prospective

study description: 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 Investigations leads to the identification of somatic or germline alterations that can enable precision therapy.
Objectives:
Primary
-Perform systematic molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor, malignancies of the blood or bone marrow, and normal tissues for the identification of biomarkers and targets for therapy.
-Identify incidental and secondary findings in germ line DNA for reporting clinical results into CRIS medical records from a Clinical Laboratory Improvement Act (CLIA) certified lab.
-Identify 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:
-Patient must be enrolled on an approved companion clinical trial within the NIH, Center for Cancer Research or approval from the ClinOmics protocol PI.
-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 (e.g. polyposis, plexiform neurofibromas, myelodysplastic syndrome); OR
-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. --For patients with a large tumor burden within the circulation for example with leukemia, skin biopsies may be performed on the companion protocol.
-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
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 designated sample investigations including systematic molecular, genomic, epigenetic and proteomic (Omics) profiling, and growth factor and cellular profile investigations.
CLIA testing activities will include:
-DNA extracted from a section of tumor, malignant tissue or bone marrow samples for somatic mutation sequence analysis.
-Germ line 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.
-Germ line DNA and RNA extraction from lymphocytes or other normal uninvolved tissue.
-Establishing Patient Derived Xenografts (PDXs), or Conditionally Reprogrammed Cells (CRC) lines, explant and cell lines established from tumor or normal samples.
-Cryopreservation of viable normal 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, Metabolomics) studies will be performed.
Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.

primary outcomes:

• 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. [ Time Frame: ongoing ]
  Sample analysis.

secondary outcomes:

• Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues [ Time Frame: ongoing ]
  Sample analysis for identification of biomarkers, drivers and medically actionable targets for clinical management.
  
• Create a tissue repository [ Time Frame: ongoing ]
  Repository for analysis of samples.
  
• Extraction and storage of circulating tumor DNA [ Time Frame: ongoing ]
  Storage of samples.
  
• Establishing Patient-derived models [ Time Frame: ongoing ]
  Analysis of samples.
  
• Cryopreservation of viable tumor tissue for future study [ Time Frame: ongoing ]
  Sample storage for future analysis.
  
• Establishment of EBV transformed cell lines for research [ Time Frame: ongoing ]
  Analysis of germline samples.
  
• Creation of an OncoGenomics oversight committee [ Time Frame: ongoing ]
  Oversight and development of new treatment approaches.
  
• Assessment of effects of the informed consent process [ Time Frame: ongoing ]
  Survey data collection and analysis.

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:

sponsor: National Cancer Institute (NCI)

contacts: Kim M Walker, (301) 594-5409, kim.walker@nih.gov

investigators: Javed Khan, M.D.

locations: United States