Metabolomics-Based Detection of Colorectal Cancer (metabolomics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507598
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):
Indiana University

July 24, 2007
July 26, 2007
September 11, 2014
July 2007
March 2009   (Final data collection date for primary 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. [ Time Frame: 1 years ]
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Complete list of historical versions of study NCT00507598 on Archive Site
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. [ Time Frame: 1 year ]
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Metabolomics-Based Detection of Colorectal Cancer
Metabolomics-Based Detection of Colorectal Cancer
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.
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.
Time Perspective: Prospective
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Retention:   Samples With DNA
serum, urine
Non-Probability Sample
colorectal cancer patients
Colorectal Cancer
Other: No intervention
Correlative study collecting serum and tissue samples
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
0706-03: IUCRO-0198
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Indiana University
Indiana University
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Principal Investigator: Elena Chiorean, MD Indiana University
Indiana University
September 2014