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Metabolomics-Based Detection of Colorectal Cancer (metabolomics)

This study is currently recruiting participants.
Verified by Indiana University, July 2008

Sponsored by: Indiana University School of Medicine
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00507598
  Purpose

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 Intervention Phase
Colorectal Cancer
Other: No intervention
Phase I

MedlinePlus related topics:   Cancer    Colorectal Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Metabolomics-Based Detection of Colorectal Cancer

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • •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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

serum, urine


Estimated Enrollment:   90
Study Start Date:   July 2007
Estimated Study Completion Date:   July 2012
Estimated Primary Completion Date:   July 2010 (Final data collection date for primary outcome measure)

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

  Eligibility
Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507598

Contacts
Contact: Janet Hernandez, RN     317-274-0972     jlastaur@iupui.edu    
Contact: Matthew Burns     317-274-8247     matburns@iupui.edu    

Locations
United States, Indiana
Indiana University Cancer Center     Recruiting
      Indianapolis, Indiana, United States, 46202
      Contact: Janet Hernandez, RN     317-274-0972     jlastuar@iupui.edu    
      Contact: Matthew Burns     317-274-8247     matburns@iupui.edu    

Sponsors and Collaborators
Indiana University School of Medicine

Investigators
Principal Investigator:     Elena Chiorean, MD     Indiana University    
  More Information


http://cancer.iu.edu/cancer/trials/findtrials.php?category=disease  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Indiana University Cancer Center ( Elena Chiorean, MD/ Principal Investigator )
Study ID Numbers:   0706-03: IUCRO-0198
First Received:   July 24, 2007
Last Updated:   July 30, 2008
ClinicalTrials.gov Identifier:   NCT00507598
Health Authority:   United States: Institutional Review Board

Keywords provided by Indiana University:
colorectal cancer  
metabolomics  

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 22, 2008




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