Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Indiana University
- Enrollment
- 551
- Locations
- 1
- Primary Endpoint
- Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer, patients with colorectal polyps and from patients without polyps may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in blood and tissue samples from patients with colorectal cancer or colorectal polyps and from patients without polyps (healthy volunteers).
Detailed Description
OBJECTIVES: Primary * Perform metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling using blood and tissue samples from patients with colorectal cancer (CRC) or colorectal adenomatous polyps and from patients without polyps. * Create an OMIC profile to predict the risk of CRC based on differences observed between patients with CRC, patients with colorectal adenomatous polyps, and patients without polyps. Secondary * Create an OMIC profile to predict response and toxicity to specific chemotherapies, biological therapies, and radiotherapy for CRC. * Utilize a novel knowledge discovery tool (BioMap) based on literature mining and, in the future, utilize the results of the OMIC analyses to identify interactive molecular pathways that underlie the development and progression of CRC. OUTLINE: Patients with locally advanced or metastatic colorectal cancer are stratified according to treatment (first-line chemotherapy with fluorouracil \[5-FU\]/oxaliplatin or 5-FU/irinotecan vs second- or third-line chemotherapy with irinotecan only vs biological therapy with bevacizumab vs biological therapy with cetuximab vs radiotherapy). Blood and tissue samples are collected periodically for laboratory studies. Samples are analyzed for metabolomics by nuclear magnetic resonance, gas chromatography, liquid chromatography, and mass spectrometry; lipidomics, proteomics, and glycoproteomics by liquid chromatography and mass spectrometry; and genomics (single nucleotide polymorphism biomarkers) by PCR. Vitamin D status is also assessed. Patients complete diet-history and lifestyle questionnaires at baseline and once a year for 2 years. Healthy volunteers complete these questionnaires only at baseline. After completion of study, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Healthy volunteers are not followed after study completion.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)
Time Frame: End of Study
Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling
Time Frame: End of Study
Secondary Outcomes
- Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC(End of Study)
- Identification of interactive molecular pathways that underlie the development and progression of CRC(End of Study)