Metabolomics-Based Detection of Colorectal Cancer
metabolomics
1 other identifier
observational
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 24, 2007
CompletedFirst Posted
Study publicly available on registry
July 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedSeptember 11, 2014
September 1, 2014
1.7 years
July 24, 2007
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
•Perform metabolic profiling of tissue,serum & urine from pts w/ colorectal cancer (stages I-IV), healthy controls & pts w/ colorectal polyps & correlate results.
1 years
Secondary Outcomes (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.
1 year
Interventions
Correlative study collecting serum and tissue samples
Eligibility Criteria
colorectal cancer patients
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Biospecimen
serum, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Chiorean, MD
Indiana University
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2007
First Posted
July 26, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2009
Study Completion
November 1, 2012
Last Updated
September 11, 2014
Record last verified: 2014-09