Colorectal CancerNCT00897403
Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy
An observational study of Colorectal Cancer and Health Status Unknown, run by Vanderbilt University at 4 sites in United States.
Trial summary
RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing colonoscopy to study in the laboratory may help doctors learn more about colon cancer and identify biomarkers related to colon cancer in the future. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Health Status Unknown
- What is being tested?
- biologic sample preservation procedure and diagnostic colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 6,446 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2006to Apr 2016
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for colonoscopy either as routine screening or for a specific problem.
DISEASE CHARACTERISTICS:
- Scheduled for colonoscopy as routine screening or for a specific problem
PATIENT CHARACTERISTICS:
- Not pregnant
PRIOR CONCURRENT THERAPY:
- No concurrent participation in a clinical trial to treat cancer or prevent cancer recurrence
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Dan Rudy Cancer Center at Saint Thomas Hospital
Nashville, Tennessee, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Discovery of Candidate Biomarkers in Colon Cancer and Precancers Repository
RATIONALE: Collecting and storing samples of blood and tissue from patients undergoing colonoscopy to study in the laboratory may help doctors learn more about colon cancer and identify biomarkers related to colon cancer in the future.
PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer biomarker studies in patients undergoing colonoscopy.
Read the detailed description
OBJECTIVES:
- Collect blood and tissue samples (including polyps, abnormal growths, cancer, and normal tissue) from patients undergoing colonoscopy.
OUTLINE: Patients undergo blood and tissue sample collection during colonoscopy. Samples are stored for future biomarker proteomic profiling.
- Conditions
- Colorectal Cancer, Health Status Unknown
- Being tested
- biologic sample preservation procedure, diagnostic colonoscopy
- Keywords
- colon cancer, health status unknown
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
diagnostic colonoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood and tissue
Measured: Pre-op & during surgery
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 startDec 2006
- Primary completionAug 2015
- Study completionApr 2016
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.
- 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
- 6,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel Liebler, Vanderbilt University Medical Center
- Investigators
- Daniel C. Liebler, PhD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897403
- Sponsor's protocol ID
- CDR0000546530
- Other IDs
- P30CA068485, VU-VICC-GI-0661, VU-VICC-IRB-061096
- Status last verified
- Apr 2017
- First submitted
- 9 May 2009
- Last updated
- 7 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Candidate Biomarkers in Colon Cancer and Precancers Repository
- ClinicalTrials.gov ID
- NCT00897403
- Acronym / sponsor ID
- CDR0000546530
- Conditions
- Colorectal Cancer, Health Status Unknown
- Keywords
- colon cancer, health status unknown
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,446 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Apr 2016 (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: Collecting and storing samples of blood and tissue from patients undergoing colonoscopy to study in the laboratory may help doctors learn more about colon cancer and identify biomarkers related to colon cancer in the future.
PURPOSE: This laboratory study is collecting blood and tissue samples for future colon cancer biomarker studies in patients undergoing colonoscopy.
Detailed description
OBJECTIVES:
- Collect blood and tissue samples (including polyps, abnormal growths, cancer, and normal tissue) from patients undergoing colonoscopy.
OUTLINE: Patients undergo blood and tissue sample collection during colonoscopy. Samples are stored for future biomarker proteomic profiling.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for colonoscopy either as routine screening or for a specific problem.
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 |
|---|---|---|
| biologic sample preservation procedure | Other | – |
| diagnostic colonoscopy | Procedure or surgery | – |
Primary outcome
Collection of blood and tissue
Time frame: Pre-op & during surgery
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 7 Apr 2017.
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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.
Daniel C. Liebler, PhD study chair
Vanderbilt-Ingram Cancer Center
4 sites 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 Health Status Unknown, run by Vanderbilt University at 4 sites 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Collection of blood and tissue (time frame: Pre-op & during surgery). 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 7 Apr 2017.