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Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

18 Years
Open (Enrolling)
Colorectal Cancer, Healthy, no Evidence of Disease, Precancerous Condition

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Trial Information

Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study



- 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


- 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

Inclusion Criteria


- 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


- 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)


- See Disease Characteristics

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling

Outcome Time Frame:

End of Study

Safety Issue:


Principal Investigator

Patrick J Loehrer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Institutional Review Board

Study ID:

0808-24; IUCRO-0221



Start Date:

January 2009

Completion Date:

January 2014

Related Keywords:

  • Colorectal Cancer
  • Healthy, no Evidence of Disease
  • Precancerous Condition
  • healthy, no evidence of disease
  • stage I colon cancer
  • stage II colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent rectal cancer
  • recurrent colon cancer
  • adenomatous polyp
  • Colorectal Neoplasms
  • Precancerous Conditions



Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289