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

September 17, 2014 updated by: Indiana University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: End of Study
End of Study
Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)
Time Frame: End of Study
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
Time Frame: End of Study
End of Study
Identification of interactive molecular pathways that underlie the development and progression of CRC
Time Frame: End of Study
End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808-24; IUCRO-0221
  • P30CA082709 (U.S. NIH Grant/Contract)
  • IUCRO-0221 (OTHER: Indiana University Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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