Metabolomics-Based Detection of Colorectal Cancer (metabolomics)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00507598
First received: July 24, 2007
Last updated: September 10, 2014
Last verified: September 2014

July 24, 2007
September 10, 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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00507598 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, urine

Non-Probability Sample

colorectal cancer patients

Colorectal Cancer
Other: No intervention
Correlative study collecting serum and tissue samples
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507598
0706-03: IUCRO-0198
Yes
Indiana University
Indiana University
Not Provided
Principal Investigator: Elena Chiorean, MD Indiana University
Indiana University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP