Metabolomics-Based Detection of Colorectal Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 24, 2007

Last Updated Date

January 6, 2009

Start Date ^†

July 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00507598 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Metabolomics-Based Detection of Colorectal Cancer

Official Title ^†

Metabolomics-Based Detection of Colorectal Cancer

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.

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 Phase

Phase I

Study Type ^†

Observational

Study Design ^†

Other, Prospective

Condition ^†

Colorectal Cancer

Intervention ^†

Other: No intervention

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

300

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Janet Flynn, RN	317-274-0972	janflynn@iupui.edu
Contact: Elena Chiorean, MD	317-278-6942	gchiorea@iupui.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00507598

Responsible Party

Elena Chiorean, MD/ Principal Investigator, Indiana University Cancer Center

Secondary IDs ^††

Study Sponsor ^†

Indiana University School of Medicine

Collaborators ^††

Investigators ^†

Principal Investigator:

Elena Chiorean, MD

Indiana University

Information Provided By

Indiana University

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.