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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

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

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: polymerase chain reaction
* Genetic: polymorphism analysis
* Genetic: protein expression analysis
* Genetic: proteomic profiling
* Other: gas chromatography
* Other: laboratory biomarker analysis
* Other: liquid chromatography
* Other: mass spectrometry
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of one of the following: Stage I or II colorectal cancer (CRC)* Planning to undergo surgery only Stage III CRC* Planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy Stage IV CRC Planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab) Colorectal adenomatous polyps Planning to undergo colonoscopy Healthy volunteer Planning to undergo colonoscopy NOTE: *Patients with previously resected stage II or III CRC are eligible provided they undergo blood sample collection prior to starting chemotherapy PATIENT CHARACTERISTICS: Not pregnant Able to undergo an 8-hour overnight fast prior to metabolomic testing Able to attend follow-up or treatment visits for up to 24 months for collection of blood samples No prior or concurrent invasive cancer other than CRC (for patients with CRC) No prior invasive cancer and no first-degree relative with a known history of CRC (for healthy volunteers and patients with colorectal polyps) PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal Cancer Patients<br>Patients with stages I/II, III and IV colorectal cancer | Genetic: gene expression analysis<br>* gene expression analysis<br>Genetic: polymerase chain reaction<br>* polymerase chain reaction<br>Genetic: polymorphism analysis<br>* polymorphism analysis<br>Genetic: protein expression analysis<br>* protein expression analysis<br>Genetic: proteomic profiling<br>* proteomic profiling<br>Other: gas chromatography<br>* gas chromatography<br>Other: laboratory biomarker analysis<br>* laboratory biomarker analysis<br>Other: liquid chromatography<br>* liquid chromatography<br>Other: mass spectrometry<br>* mass spectrometry<br>Other: questionnaire administration<br>* questionnaire administration<br>|
| Colorectal Polyps Patients<br>Patients with adenomatous polyp(s) after colonoscopy. | Genetic: gene expression analysis<br>* gene expression analysis<br>Genetic: polymerase chain reaction<br>* polymerase chain reaction<br>Genetic: polymorphism analysis<br>* polymorphism analysis<br>Genetic: protein expression analysis<br>* protein expression analysis<br>Genetic: proteomic profiling<br>* proteomic profiling<br>Other: gas chromatography<br>* gas chromatography<br>Other: laboratory biomarker analysis<br>* laboratory biomarker analysis<br>Other: liquid chromatography<br>* liquid chromatography<br>Other: mass spectrometry<br>* mass spectrometry<br>Other: questionnaire administration<br>* questionnaire administration<br>|
| Healthy Controls<br>No abnormalities after colonoscopy. | Genetic: gene expression analysis<br>* gene expression analysis<br>Genetic: polymerase chain reaction<br>* polymerase chain reaction<br>Genetic: polymorphism analysis<br>* polymorphism analysis<br>Genetic: protein expression analysis<br>* protein expression analysis<br>Genetic: proteomic profiling<br>* proteomic profiling<br>Other: gas chromatography<br>* gas chromatography<br>Other: laboratory biomarker analysis<br>* laboratory biomarker analysis<br>Other: liquid chromatography<br>* liquid chromatography<br>Other: mass spectrometry<br>* mass spectrometry<br>Other: questionnaire administration<br>* questionnaire administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling |  | End of Study | 
| Creation of an OMIC profile to predict the risk of colorectal cancer (CRC) |  | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, no evidence of disease, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent rectal cancer, recurrent colon cancer, adenomatous polyp