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Metabolomics-Based Detection of Colorectal Cancer

Phase 1
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Metabolomics-Based Detection of Colorectal Cancer

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.

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

- 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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

1 years

Safety Issue:


Principal Investigator

Elena Chiorean, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Institutional Review Board

Study ID:

0706-03: IUCRO-0198



Start Date:

July 2007

Completion Date:

November 2012

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • metabolomics
  • Colorectal Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265