Status:
COMPLETED
Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Healthy, no Evidence of Disease
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer, patients with colorectal polyps and from patients without polyps may help doctors learn more about changes ...
Detailed Description
OBJECTIVES: Primary * Perform metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling using blood and tissue samples from patients with colorectal cancer (CRC) or colorectal ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Diagnosis of one of the following:
- Stage I or II colorectal cancer (CRC)\*
- Planning to undergo surgery only
- Stage III CRC\*
- Planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy
- Stage IV CRC
- Planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab)
- Colorectal adenomatous polyps
- Planning to undergo colonoscopy
- Healthy volunteer
- Planning to undergo colonoscopy NOTE: \*Patients with previously resected stage II or III CRC are eligible provided they undergo blood sample collection prior to starting chemotherapy
- PATIENT CHARACTERISTICS:
- Not pregnant
- Able to undergo an 8-hour overnight fast prior to metabolomic testing
- Able to attend follow-up or treatment visits for up to 24 months for collection of blood samples
- No prior or concurrent invasive cancer other than CRC (for patients with CRC)
- No prior invasive cancer and no first-degree relative with a known history of CRC (for healthy volunteers and patients with colorectal polyps)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00898378
Start Date
January 1 2009
End Date
March 1 2014
Last Update
September 18 2014
Active Locations (1)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289