|
|
|
|
|
Sponsored by: |
Indiana University School of Medicine |
Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00507598 |
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 |
Study Type: | Observational |
Study Design: | Other, Prospective |
Official Title: | Metabolomics-Based Detection of Colorectal Cancer |
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) |
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.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
colorectal cancer patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Janet Hernandez, RN | 317-274-0972 | jlastaur@iupui.edu |
Contact: Matthew Burns | 317-274-8247 | matburns@iupui.edu |
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 |
Indiana University School of Medicine |
Principal Investigator: | Elena Chiorean, MD | Indiana University |
http://cancer.iu.edu/cancer/trials/findtrials.php?category=disease 
  |
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 |
|
|
|
|