Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

NCT03027401 | Withdrawn

• 2 other identifiers: 17004017-C-0040
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neoplasms; Adenomatous Polyposis Coli; Neurofibroma, Plexiform; Myelodysplastic Syndromes

Keywords

Genetic Testing; Tumor Profiling; Biorepository

Outcome Measures

Primary Outcomes (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.

  Sample analysis.

  ongoing

Secondary Outcomes (8)

• Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues

  ongoing

• Create a tissue repository

  ongoing

• Extraction and storage of circulating tumor DNA

  ongoing

• Establishing Patient-derived models

  ongoing

• Cryopreservation of viable tumor tissue for future study

  ongoing

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples for the population cohort will be selected from patients that are co-enrolled on other NIH protocols (both inpatient and outpatient) as well as community referrals from outside NIH.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, Martin CL, McGuire AL, Nussbaum RL, O'Daniel JM, Ormond KE, Rehm HL, Watson MS, Williams MS, Biesecker LG; American College of Medical Genetics and Genomics. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med. 2013 Jul;15(7):565-74. doi: 10.1038/gim.2013.73. Epub 2013 Jun 20.

  PMID: 23788249 BACKGROUND

• Weiner C. Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues). Am J Epidemiol. 2014 Sep 15;180(6):562-4. doi: 10.1093/aje/kwu217. Epub 2014 Aug 22.

  PMID: 25150271 BACKGROUND

• Appelbaum PS, Waldman CR, Fyer A, Klitzman R, Parens E, Martinez J, Price WN 2nd, Chung WK. Informed consent for return of incidental findings in genomic research. Genet Med. 2014 May;16(5):367-73. doi: 10.1038/gim.2013.145. Epub 2013 Oct 24.

  PMID: 24158054 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Adenomatous Polyposis Coli; Neurofibroma, Plexiform; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Javed Khan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: January 10, 2017
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)