Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps

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.

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