Clinical trial NCT00898378: Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps
Official title: Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Healthy, no Evidence of Disease
Precancerous Condition
Keywords: 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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited via oncology, gastroenterology and surgical oncology clinics at Indiana University Medical Center. Healthy controls will be subjects without any abnormalities after a colonoscopy. Subjects with polyps will be those whose colonoscopy identifies adenomatous polyps (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").

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 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).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling
timeFrame: End of Study
measure: Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)
timeFrame: End of Study
Secondary outcomes:
measure: Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC
timeFrame: End of Study
measure: Identification of interactive molecular pathways that underlie the development and progression of CRC
timeFrame: End of Study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Patrick J Loehrer, MD
role: PRINCIPAL_INVESTIGATOR
References: