Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps
NCT ID: NCT00898378
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
551 participants
OBSERVATIONAL
2009-01-31
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients
NCT00899626
Presence of Circulating Tumor DNA in Colorectal Cancer
NCT01198743
Metabolomics-Based Detection of Colorectal Cancer
NCT00507598
Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy
NCT00897403
Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers
NCT03563651
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Colorectal Cancer Patients
Patients with stages I/II, III and IV colorectal cancer
gene expression analysis
gene expression analysis
polymerase chain reaction
polymerase chain reaction
polymorphism analysis
polymorphism analysis
protein expression analysis
protein expression analysis
proteomic profiling
proteomic profiling
gas chromatography
gas chromatography
laboratory biomarker analysis
laboratory biomarker analysis
liquid chromatography
liquid chromatography
mass spectrometry
mass spectrometry
questionnaire administration
questionnaire administration
Colorectal Polyps Patients
Patients with adenomatous polyp(s) after colonoscopy.
gene expression analysis
gene expression analysis
polymerase chain reaction
polymerase chain reaction
polymorphism analysis
polymorphism analysis
protein expression analysis
protein expression analysis
proteomic profiling
proteomic profiling
gas chromatography
gas chromatography
laboratory biomarker analysis
laboratory biomarker analysis
liquid chromatography
liquid chromatography
mass spectrometry
mass spectrometry
questionnaire administration
questionnaire administration
Healthy Controls
No abnormalities after colonoscopy.
gene expression analysis
gene expression analysis
polymerase chain reaction
polymerase chain reaction
polymorphism analysis
polymorphism analysis
protein expression analysis
protein expression analysis
proteomic profiling
proteomic profiling
gas chromatography
gas chromatography
laboratory biomarker analysis
laboratory biomarker analysis
liquid chromatography
liquid chromatography
mass spectrometry
mass spectrometry
questionnaire administration
questionnaire administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gene expression analysis
gene expression analysis
polymerase chain reaction
polymerase chain reaction
polymorphism analysis
polymorphism analysis
protein expression analysis
protein expression analysis
proteomic profiling
proteomic profiling
gas chromatography
gas chromatography
laboratory biomarker analysis
laboratory biomarker analysis
liquid chromatography
liquid chromatography
mass spectrometry
mass spectrometry
questionnaire administration
questionnaire administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Indiana University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick J Loehrer, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University Melvin and Bren Simon Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IUCRO-0221
Identifier Type: OTHER
Identifier Source: secondary_id
0808-24; IUCRO-0221
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.