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

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Precancerous Condition; Healthy, no Evidence of Disease
• Intervention / Treatment: Other: laboratory biomarker analysis; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Genetic: protein expression analysis; Genetic: proteomic profiling; Other: gas chromatography; Other: liquid chromatography; Other: mass spectrometry; Other: questionnaire administration

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.

• Study Type: Observational
• Enrollment (Actual): 551

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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").

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal Cancer Patients; Patients with stages I/II, III and IV colorectal cancer	Other: laboratory biomarker analysis; laboratory biomarker analysis; Genetic: gene expression analysis; gene expression analysis; Genetic: polymerase chain reaction; polymerase chain reaction; Genetic: polymorphism analysis; polymorphism analysis; Genetic: protein expression analysis; protein expression analysis; Genetic: proteomic profiling; proteomic profiling; Other: gas chromatography; gas chromatography; Other: liquid chromatography; liquid chromatography; Other: mass spectrometry; mass spectrometry; Other: questionnaire administration; questionnaire administration
Colorectal Polyps Patients; Patients with adenomatous polyp(s) after colonoscopy.	Other: laboratory biomarker analysis; laboratory biomarker analysis; Genetic: gene expression analysis; gene expression analysis; Genetic: polymerase chain reaction; polymerase chain reaction; Genetic: polymorphism analysis; polymorphism analysis; Genetic: protein expression analysis; protein expression analysis; Genetic: proteomic profiling; proteomic profiling; Other: gas chromatography; gas chromatography; Other: liquid chromatography; liquid chromatography; Other: mass spectrometry; mass spectrometry; Other: questionnaire administration; questionnaire administration
Healthy Controls; No abnormalities after colonoscopy.	Other: laboratory biomarker analysis; laboratory biomarker analysis; Genetic: gene expression analysis; gene expression analysis; Genetic: polymerase chain reaction; polymerase chain reaction; Genetic: polymorphism analysis; polymorphism analysis; Genetic: protein expression analysis; protein expression analysis; Genetic: proteomic profiling; proteomic profiling; Other: gas chromatography; gas chromatography; Other: liquid chromatography; liquid chromatography; Other: mass spectrometry; mass spectrometry; Other: questionnaire administration; questionnaire administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling	End of Study
Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)	End of Study

Secondary Outcome Measures

Outcome Measure	Time Frame
Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC	End of Study
Identification of interactive molecular pathways that underlie the development and progression of CRC	End of Study

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Patrick J Loehrer, MD, Indiana University Melvin and Bren Simon Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (ESTIMATE): May 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: stage IV rectal cancer; stage IV colon cancer; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer; stage I rectal cancer; stage I colon cancer; healthy, no evidence of disease; adenomatous polyp
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Precancerous Conditions
• Other Study ID Numbers: 0808-24; IUCRO-0221; P30CA082709 (U.S. NIH Grant/Contract); IUCRO-0221 (OTHER: Indiana University Cancer Center)