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OpenTrials
Completed

NCT Number: NCT00898378

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

gene expression analysis

polymerase chain reaction

Genetic

polymerase chain reaction

polymorphism analysis

Genetic

polymorphism analysis

protein expression analysis

Genetic

protein expression analysis

proteomic profiling

Genetic

proteomic profiling

gas chromatography

Other

gas chromatography

laboratory biomarker analysis

Other

laboratory biomarker analysis

liquid chromatography

Other

liquid chromatography

mass spectrometry

Other

mass spectrometry

Questionnaire Administration

Other

questionnaire administration

Primary outcomes

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

    Time frame: End of Study

  2. Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)

    Time frame: End of Study

Secondary outcomes

  1. Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC

    Time frame: End of Study

  2. Identification of interactive molecular pathways that underlie the development and progression of CRC

    Time frame: End of Study

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 12, 2009
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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