Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics
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|ClinicalTrials.gov Identifier: NCT03027401|
Recruitment Status : Withdrawn (closed by PI and FDA)
First Posted : January 23, 2017
Last Update Posted : October 8, 2020
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.
To find the DNA changes in cancer that may help guide treatment. To collect samples and data to be used in future studies.
People any age with cancer or a pre-cancerous tumor
- 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.
|Condition or disease|
|Neoplasms Adenomatous Polyposis Coli Neurofibroma, Plexiform Myelodysplastic Syndromes|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Clinical Sequencing of Cancer and Tissue Repository: ClinOmics|
|Actual Study Start Date :||January 10, 2017|
|Actual Primary Completion Date :||October 5, 2020|
|Actual Study Completion Date :||October 5, 2020|
Adult/pediatric with suspected or confirmed malignancy, family history of malignancy, undergoing surgery with no malignancy; tissues collected previously under CLIA or for research.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027401
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Javed Khan, M.D.||National Cancer Institute (NCI)|