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Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03027401
Recruitment Status : Not yet recruiting
First Posted : January 23, 2017
Last Update Posted : February 14, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Sequencing of Cancer and Tissue Repository: ClinOmics
Study Start Date : January 10, 2017
Estimated Primary Completion Date : August 1, 2035
Estimated Study Completion Date : August 1, 2035

Group A
Adult/pediatric with suspected or confirmed malignancy, family history of malignancy, undergoing surgery with no malignancy; tissues collected previously under CLIA or for research.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Create a tissue repository [ Time Frame: ongoing ]
    Repository for analysis of samples.

  3. Extraction and storage of circulating tumor DNA [ Time Frame: ongoing ]
    Storage of samples.

  4. Establishing Patient-derived models [ Time Frame: ongoing ]
    Analysis of samples.

  5. Cryopreservation of viable tumor tissue for future study [ Time Frame: ongoing ]
    Sample storage for future analysis.

  6. Establishment of EBV transformed cell lines for research [ Time Frame: ongoing ]
    Analysis of germline samples.

  7. Creation of an OncoGenomics oversight committee [ Time Frame: ongoing ]
    Oversight and development of new treatment approaches.

  8. Assessment of effects of the informed consent process [ Time Frame: ongoing ]
    Survey data collection and analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Information from the National Library of Medicine

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 identifier (NCT number): NCT03027401

Contact: Kim M Walker, R.N. (240) 760-6099

United States, Maryland
National Institutes of Health Clinical Center Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information AskClinOmics    844-436-0642   
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Javed Khan, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT03027401     History of Changes
Other Study ID Numbers: 170040
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: January 25, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Genetic Testing
Tumor Profiling

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Nerve Sheath Neoplasms
Adenomatous Polyposis Coli
Neurofibroma, Plexiform
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms