Colorectal Cancer Clinical Trial
Official title:
Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study
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 that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in blood and tissue samples from
patients with colorectal cancer or colorectal polyps and from patients without polyps
(healthy volunteers).
OBJECTIVES:
Primary
- Perform metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling
using blood and tissue samples from patients with colorectal cancer (CRC) or colorectal
adenomatous polyps and from patients without polyps.
- Create an OMIC profile to predict the risk of CRC based on differences observed between
patients with CRC, patients with colorectal adenomatous polyps, and patients without
polyps.
Secondary
- Create an OMIC profile to predict response and toxicity to specific chemotherapies,
biological therapies, and radiotherapy for CRC.
- Utilize a novel knowledge discovery tool (BioMap) based on literature mining and, in
the future, utilize the results of the OMIC analyses to identify interactive molecular
pathways that underlie the development and progression of CRC.
OUTLINE: Patients with locally advanced or metastatic colorectal cancer are stratified
according to treatment (first-line chemotherapy with fluorouracil [5-FU]/oxaliplatin or
5-FU/irinotecan vs second- or third-line chemotherapy with irinotecan only vs biological
therapy with bevacizumab vs biological therapy with cetuximab vs radiotherapy).
Blood and tissue samples are collected periodically for laboratory studies. Samples are
analyzed for metabolomics by nuclear magnetic resonance, gas chromatography, liquid
chromatography, and mass spectrometry; lipidomics, proteomics, and glycoproteomics by liquid
chromatography and mass spectrometry; and genomics (single nucleotide polymorphism
biomarkers) by PCR. Vitamin D status is also assessed.
Patients complete diet-history and lifestyle questionnaires at baseline and once a year for
2 years. Healthy volunteers complete these questionnaires only at baseline.
After completion of study, patients are followed every 3 months for 2 years, every 6 months
for 3 years, and then annually thereafter. Healthy volunteers are not followed after study
completion.
;
Observational Model: Case Control, Time Perspective: Prospective
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