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Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

This study is not yet open for participant recruitment.
Verified October 24, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03027401
First Posted: January 23, 2017
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

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.

Condition
Neoplasms Adenomatous Polyposis Coli Neurofibroma, Plexiform Myelodysplastic Syndromes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5000
Study Start Date: January 10, 2017
Estimated Study Completion Date: August 1, 2035
Estimated Primary Completion Date: August 1, 2035 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03027401


Contacts
Contact: Kim M Walker, R.N. (240) 760-6099 kim.walker@nih.gov

Locations
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    askclinomics@mail.nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Javed Khan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03027401     History of Changes
Other Study ID Numbers: 170040
17-C-0040
First Submitted: January 19, 2017
First Posted: January 23, 2017
Last Update Posted: November 8, 2017
Last Verified: October 24, 2017

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Neurofibroma
Neurofibromatoses
Nerve Sheath Neoplasms
Adenomatous Polyposis Coli
Neurofibroma, Plexiform
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
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
Adenoma
Neoplasms, Glandular and Epithelial
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms