NCT00898378

Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps

Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 551 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Healthy, no Evidence of Disease
• Precancerous Condition

Interventions

Type	Name	Description
GENETIC	gene expression analysis	gene expression analysis
GENETIC	polymerase chain reaction	polymerase chain reaction
GENETIC	polymorphism analysis	polymorphism analysis
GENETIC	protein expression analysis	protein expression analysis
GENETIC	proteomic profiling	proteomic profiling
OTHER	gas chromatography	gas chromatography
OTHER	laboratory biomarker analysis	laboratory biomarker analysis
OTHER	liquid chromatography	liquid chromatography
OTHER	mass spectrometry	mass spectrometry
OTHER	questionnaire administration	questionnaire administration

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2009-05-12
• Last updated: 2014-09-18

Locations

1 site across 1 country: United States