Metabolomics-Based Detection of Colorectal Cancer

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00507598
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.

Detailed Description

In this study, metabolite profiling analysis will be carried out on colon cancer patients at the time of diagnosis and during the course of treatment, using patient tissue and serum samples. Samples of serum (1 ml) and tissue specimens (50 mg each) from colorectal cancer patients (stages I-IV) and serum samples from an equal number of age and gender-matched healthy controls will be obtained under identical (8-hour overnight fasting) conditions. Metabolic profiles will be identified using the NMR and MS instruments located in Purdue's on-campus NMR and MS facilities. Multivariate statistical analyses will be used to monitor changing metabolite profiles that indicate changes in disease status. We anticipate that putative biomarkers will be easier to identify in the cancerous tissue, and the concentrations of these metabolites will then be quantified in the patients' serum, that ultimately would allow for easier detection of colon cancer.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-26
• Primary Completion: 2009-03
• Study Completion: 2012-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
• Patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
• Subjects must be ≥ 18 years of age.
• Subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
• For patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol Schema.
• Subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens.
• Female patients known to be pregnant are not eligible for this protocol.
• Subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing

Exclusion Criteria

• Presence of an invasive cancer other than colorectal cancer is an exclusion criterion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Perform metabolic profiling of tissue,serum & urine from pts w/ colorectal cancer (stages I-IV), healthy controls & pts w/ colorectal polyps & correlate results.	1 years

Secondary Outcome Measures

Name	Time	Method
Correlate changes of serum & urine biomarkers /p trt to predict response or toxicity,& correlate w/other treatment outcomes. Compare the metabolic profile between pts w/various stages of colorectal cancer.	1 year

Trial Locations

Locations (1)

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States