Colorectal CancerNCT00898378
Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps
An observational study of Colorectal Cancer and Healthy, no Evidence of Disease, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Healthy, no Evidence of Disease, Precancerous Condition
- What is being tested?
- gene expression analysis, polymerase chain reaction and polymorphism analysis
- Type of treatment
- Injection or infusion
- How many people
- 551 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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").
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
About this study
Official title: 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).
Read the 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.
- Being tested
- gene expression analysis, polymerase chain reaction, polymorphism analysis, protein expression analysis, proteomic profiling
- Keywords
- 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
- Medical subject headings
- Colorectal Neoplasms, Precancerous Conditions, Colonic Neoplasms, Rectal Neoplasms, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
gene expression analysis
polymerase chain reactionGenetic
polymerase chain reaction
polymorphism analysisGenetic
polymorphism analysis
protein expression analysisGenetic
protein expression analysis
proteomic profilingGenetic
proteomic profiling
gas chromatographyOther
gas chromatography
laboratory biomarker analysisOther
laboratory biomarker analysis
liquid chromatographyOther
liquid chromatography
mass spectrometryOther
mass spectrometry
questionnaire administrationOther
questionnaire administration
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Patients | Patients with stages I/II, III and IV colorectal cancer Receives: 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 | |
| Colorectal Polyps Patients | Patients with adenomatous polyp(s) after colonoscopy. Receives: 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 | |
| Healthy Controls | No abnormalities after colonoscopy. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling
Measured: End of Study
Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)
Measured: End of Study
Secondary outcomes (2)
Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC
Measured: End of Study
Identification of interactive molecular pathways that underlie the development and progression of CRC
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick J Loehrer, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898378
- Sponsor's protocol ID
- 0808-24; IUCRO-0221
- Other IDs
- P30CA082709, IUCRO-0221
- Status last verified
- Sep 2014
- First submitted
- 9 May 2009
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Care Engineering of Colorectal Cancer - OMICs Pilot Study
- ClinicalTrials.gov ID
- NCT00898378
- Acronym / sponsor ID
- 0808-24; IUCRO-0221
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Patients | – | 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 administrationPatients with stages I/II, III and IV colorectal cancer |
| Colorectal Polyps Patients | – | 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 administrationPatients with adenomatous polyp(s) after colonoscopy. |
| Healthy Controls | – | 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 administrationNo abnormalities after colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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").
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysisgene expression analysis | Genetic | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| polymerase chain reactionpolymerase chain reaction | Genetic | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| polymorphism analysispolymorphism analysis | Genetic | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| protein expression analysisprotein expression analysis | Genetic | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| proteomic profilingproteomic profiling | Genetic | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| gas chromatographygas chromatography | Other | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| laboratory biomarker analysislaboratory biomarker analysis | Other | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| liquid chromatographyliquid chromatography | Other | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| mass spectrometrymass spectrometry | Other | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
| questionnaire administrationquestionnaire administration | Other | Colorectal Cancer Patients, Colorectal Polyps Patients, Healthy Controls |
Primary outcome
Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling
Time frame: End of Study
Creation of an OMIC profile to predict the risk of colorectal cancer (CRC)
Time frame: End of Study
2 secondary outcomes
Creation of an OMIC profile to predict response and toxicity to specific therapies for CRC
Time frame: End of Study
Identification of interactive molecular pathways that underlie the development and progression of CRC
Time frame: End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Loehrer, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Healthy, no Evidence of Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic, lipidomic, glycoproteomic, proteomic, and genomic (OMIC) profiling (time frame: End of Study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.