Colorectal CancermetabolomicsNCT00507598
Metabolomics-Based Detection of Colorectal Cancer
An observational study of Colorectal Cancer, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Nov 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: colorectal cancer patients
Who may be able to join
- Patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
- Patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
- Subjects must be ≥ 18 years of age.
- Subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
- For patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol Schema.
- Subjects must be able to attend follow up or treatment visits per investigator's recommendations for up to 24 months for collection of serum/urine specimens.
- Female patients known to be pregnant are not eligible for this protocol.
- Subjects must be able to undergo an 8-hr overnight fast prior to metabolomic testing
Who cannot join
- Presence of an invasive cancer other than colorectal cancer is an exclusion criterion
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.
Read the detailed description
In this study, metabolite profiling analysis will be carried out on colon cancer patients at the time of diagnosis and during the course of treatment, using patient tissue and serum samples. Samples of serum (1 ml) and tissue specimens (50 mg each) from colorectal cancer patients (stages I-IV) and serum samples from an equal number of age and gender-matched healthy controls will be obtained under identical (8-hour overnight fasting) conditions. Metabolic profiles will be identified using the NMR and MS instruments located in Purdue's on-campus NMR and MS facilities. Multivariate statistical analyses will be used to monitor changing metabolite profiles that indicate changes in disease status. We anticipate that putative biomarkers will be easier to identify in the cancerous tissue, and the concentrations of these metabolites will then be quantified in the patients' serum, that ultimately would allow for easier detection of colon cancer.
- Conditions
- Colorectal Cancer
- Being tested
- No intervention
- Keywords
- colorectal cancer, metabolomics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Correlative study collecting serum and tissue samples
What is being measured
The primary outcome is the main question the study is designed to answer.
•Perform metabolic profiling of tissue,serum & urine from pts w/ colorectal cancer (stages I-IV), healthy controls & pts w/ colorectal polyps & correlate results.
Measured: 1 years
Secondary outcomes (1)
Correlate changes of serum & urine biomarkers /p trt to predict response or toxicity,& correlate w/other treatment outcomes. Compare the metabolic profile between pts w/various stages of colorectal cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionNov 2012
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
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Chiorean, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507598
- Sponsor's protocol ID
- 0706-03: IUCRO-0198
- Acronym
- metabolomics
- Status last verified
- Sep 2014
- First submitted
- 24 Jul 2007
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics-Based Detection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00507598
- Acronym / sponsor ID
- metabolomics / 0706-03: IUCRO-0198
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Jul 2007 (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.
The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.
Detailed description
In this study, metabolite profiling analysis will be carried out on colon cancer patients at the time of diagnosis and during the course of treatment, using patient tissue and serum samples. Samples of serum (1 ml) and tissue specimens (50 mg each) from colorectal cancer patients (stages I-IV) and serum samples from an equal number of age and gender-matched healthy controls will be obtained under identical (8-hour overnight fasting) conditions. Metabolic profiles will be identified using the NMR and MS instruments located in Purdue's on-campus NMR and MS facilities. Multivariate statistical analyses will be used to monitor changing metabolite profiles that indicate changes in disease status. We anticipate that putative biomarkers will be easier to identify in the cancerous tissue, and the concentrations of these metabolites will then be quantified in the patients' serum, that ultimately would allow for easier detection of colon cancer.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer patients
Key inclusion criteria (8 listed)
- Patients with resectable colorectal cancer must have samples collected (serum/urine) prior to surgery and/or after surgery, but prior to starting chemotherapy.
- Patients with metastatic colorectal cancer must have samples collected prior to initiating chemotherapy, and after chemotherapy initiation: every 3 months for up to 24 months.
- Subjects must be ≥ 18 years of age.
- Subjects undergoing screening colonoscopy are able to participate as healthy controls or as patients with colon polyps if colonoscopy identifies colon polyps being present (informed consent will be signed first and samples will be collected; after colonoscopy the samples will be identified as "healthy" or "polyps").
- For patients who underwent biopsy or surgery for colorectal cancer, enough tissue needs to be available for testing, as appropriate per patients groups in the protocol Schema.
Key exclusion criteria (1 listed)
- Presence of an invasive cancer other than colorectal cancer is an exclusion criterion
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 |
|---|---|---|
| No interventionCorrelative study collecting serum and tissue samples | Other | – |
Primary outcome
•Perform metabolic profiling of tissue,serum & urine from pts w/ colorectal cancer (stages I-IV), healthy controls & pts w/ colorectal polyps & correlate results.
Time frame: 1 years
1 secondary outcome
Correlate changes of serum & urine biomarkers /p trt to predict response or toxicity,& correlate w/other treatment outcomes. Compare the metabolic profile between pts w/various stages of colorectal cancer.
Time frame: 1 year
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 11 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.
Elena Chiorean, 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, 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?
The sponsor lists 8 inclusion and 1 exclusion criteria. 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 11 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?
•Perform metabolic profiling of tissue,serum & urine from pts w/ colorectal cancer (stages I-IV), healthy controls & pts w/ colorectal polyps & correlate results. (time frame: 1 years). 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 11 Sep 2014.