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

This study is currently recruiting participants.
Verified March 2013 by Indiana University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00898378
First received: May 9, 2009
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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).


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Creation of an OMIC profile to predict the risk of colorectal cancer (CRC) [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
  • Identification of interactive molecular pathways that underlie the development and progression of CRC [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimens will be analyzed to study metabolimics, lipidomics, genomics, glycoproteomics, global proteomics and Vitamin D status.


Estimated Enrollment: 810
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Colorectal Cancer Patients
Patients with stages I/II, III and IV colorectal cancer
 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: laboratory biomarker analysis
laboratory biomarker analysis
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.
 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: laboratory biomarker analysis
laboratory biomarker analysis
Other: liquid chromatography
liquid chromatography
Other: mass spectrometry
mass spectrometry
Other: questionnaire administration
questionnaire administration
Healthy Controls
No abnormalities after colonoscopy.
 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: laboratory biomarker analysis
laboratory biomarker analysis
Other: liquid chromatography
liquid chromatography
Other: mass spectrometry
mass spectrometry
Other: questionnaire administration
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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").

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898378

Contacts
Contact: Janet Flynn, RN 317-274-0972 janflynn@iupui.edu
Contact: Patrick Loehrer, MD 317-944-0920 ploehrer@iupui.edu

Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Janet Flynn, RN     317-274-0972     janflynn@iupui.edu    
Contact: Patrick Loehrer, MD     317-944-0920     ploehrer@iupui.edu    
Sponsors and Collaborators
Indiana University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Patrick J Loehrer, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00898378     History of Changes
Other Study ID Numbers: 0808-24; IUCRO-0221, P30CA082709, IUCRO-0221
Study First Received: May 9, 2009
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013