Clinical trial · Observational
Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics
Clinical Sequencing of Cancer and Tissue Repository: ClinOmics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): closed by PI and FDA
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyposis Coli | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neurofibroma, Plexiform | Plexiform Neurofibroma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Group A
- description
- 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 outcomes (1)
- measure
- 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.
- timeFrame
- ongoing
- description
- Sample analysis.
Secondary outcomes (8)
- measure
- Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues
- timeFrame
- ongoing
- description
- Sample analysis for identification of biomarkers, drivers and medically actionable targets for clinical management.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 99 Years
Show eligibility criteria text
* 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: -None
References
Publications (3)
- BACKGROUNDGreen 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
- BACKGROUNDWeiner 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
- BACKGROUNDAppelbaum 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