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

Completed

• Conditions: Precancerous Condition; Colorectal Cancer; Healthy, no Evidence of Disease
• Interventions: 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

• Registration Number: NCT00898378
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 551

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer Patients	protein expression analysis	Patients with stages I/II, III and IV colorectal cancer
Colorectal Polyps Patients	polymerase chain reaction	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	mass spectrometry	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	questionnaire administration	Patients with adenomatous polyp(s) after colonoscopy.
Healthy Controls	proteomic profiling	No abnormalities after colonoscopy.
Healthy Controls	gas chromatography	No abnormalities after colonoscopy.
Healthy Controls	liquid chromatography	No abnormalities after colonoscopy.
Colorectal Cancer Patients	gas chromatography	Patients with stages I/II, III and IV colorectal cancer
Colorectal Cancer Patients	mass spectrometry	Patients with stages I/II, III and IV colorectal cancer
Healthy Controls	gene expression analysis	No abnormalities after colonoscopy.
Healthy Controls	polymerase chain reaction	No abnormalities after colonoscopy.
Colorectal Cancer Patients	proteomic profiling	Patients with stages I/II, III and IV colorectal cancer
Colorectal Cancer Patients	questionnaire administration	Patients with stages I/II, III and IV colorectal cancer
Healthy Controls	protein expression analysis	No abnormalities after colonoscopy.
Healthy Controls	mass spectrometry	No abnormalities after colonoscopy.
Colorectal Cancer Patients	polymerase chain reaction	Patients with stages I/II, III and IV colorectal cancer
Colorectal Cancer Patients	polymorphism analysis	Patients with stages I/II, III and IV colorectal cancer
Colorectal Cancer Patients	laboratory biomarker analysis	Patients with stages I/II, III and IV colorectal cancer
Colorectal Polyps Patients	gene expression analysis	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	proteomic profiling	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	gas chromatography	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Cancer Patients	gene expression analysis	Patients with stages I/II, III and IV colorectal cancer
Colorectal Cancer Patients	liquid chromatography	Patients with stages I/II, III and IV colorectal cancer
Colorectal Polyps Patients	polymorphism analysis	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	protein expression analysis	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	laboratory biomarker analysis	Patients with adenomatous polyp(s) after colonoscopy.
Colorectal Polyps Patients	liquid chromatography	Patients with adenomatous polyp(s) after colonoscopy.
Healthy Controls	polymorphism analysis	No abnormalities after colonoscopy.
Healthy Controls	laboratory biomarker analysis	No abnormalities after colonoscopy.
Healthy Controls	questionnaire administration	No abnormalities after colonoscopy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States