Clinical Trial: Clinical Sequencing of Cancer and Tissue Repository: ClinOmics
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Clinical Sequencing of Cancer and Tissue Repository: ClinOmics
Brief Summary:
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 wi
Detailed Summary:
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 undergo
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- Perform systematic molecular, genomic, transcriptomic, proteomic,metabolomics and other high throughput (Omics) profiling ontumor, blood or bone marrow, and normal tissues [ Time Frame: ongoing ]
- Identify incidental findings in germ line DNA for reporting clinical results into CRIS medical records from a Clinical Laboratory Improvement Act (CLIA) certified lab [ Time Frame: ongoing ]
- Identify actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records [ Time Frame: ongoing ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: January 19, 2017
Date Started: January 10, 2017
Date Completion: August 1, 2035
Last Updated: April 21, 2017
Last Verified: February 3, 2017
