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Metabolomics-Based Detection of Colorectal Cancer (metabolomics)

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ClinicalTrials.gov Identifier: NCT00507598
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: No intervention Phase 1

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 Design

Study Type : Observational
Actual Enrollment : 69 participants
Time Perspective: Prospective
Official Title: Metabolomics-Based Detection of Colorectal Cancer
Study Start Date : July 2007
Primary Completion Date : March 2009
Study Completion Date : November 2012

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U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: No intervention
    Correlative study collecting serum and tissue samples

Outcome Measures

Primary Outcome Measures :
  1. •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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
serum, urine

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
colorectal cancer patients
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507598


Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Elena Chiorean, MD Indiana University
More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00507598     History of Changes
Other Study ID Numbers: 0706-03: IUCRO-0198
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Indiana University:
colorectal cancer
metabolomics

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases