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NCT01239082 · ClinicalTrials.gov registry record · NA
Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM)
A NA study of Colorectal Cancer, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 50,126
- Enrollment target
- 20
- Study locations
NCT01239082: Active NA study of Colorectal Cancer, sponsored by VA Office of Research and Development.
NCT01239082 is a NA study of Colorectal Cancer that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 50,126 participants, above the 1,375-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (3546% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239082, a NA study of Colorectal Cancer, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 50,126 participants
- Enrollment target
- 20
- Study locations
Study Summary
Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces CRC mortality by 13-33%. While there is strong consensus amongst experts regarding the value of CRC screening, the best approach to screening is not clear. Of the widely recommended modalities, FOBT and colonoscopy are the most commonly used within the United States. FOBT is inexpensive, non-invasive, and its use as a screening tool is supported by the highest quality evidence (i.e. randomized controlled trials). Moreover, newer FOBT, such as fecal immunochemical tests or FITs, have advantages over conventional FOBT in terms of both test characteristics and ease of use that make them quite attractive as a population-based screening tool. While colonoscopy is invasive and has higher up-front risks and costs than FOBT, it does afford the opportunity to directly assess the colonic mucosa and is widely believed to be the best test to detect colorectal cancer. In addition, colonoscopy allows for the detection and removal of colorectal adenomas -a well recognized colorectal cancer precursor. There is indirect evidence that suggests colonoscopy is effective in reducing colorectal cancer mortality, but to date, no large clinical trials have been completed to support this assumption. While colonoscopy use is increasing, data is emerging that colonoscopy may not be as effective as previously believed. Prior support for colonoscopy as a screening test relied upon effectiveness estimates that now appear to be overly optimistic. Given the invasive nature of colonoscopy, the associated small, but real risk of complications, and dramatically higher costs than other screening tests, it is especially important to determine the true comparative effectiveness of colonoscopy relative to other proven non-invasive options. T
Conditions Studied
Interventions
- PROCEDURE Colonoscopy
- PROCEDURE FIT
Study Locations (20)
California
- VA Central California Health Care System, Fresno, CA - Fresno
- VA Loma Linda Healthcare System, Loma Linda, CA - Loma Linda
- VA Long Beach Healthcare System, Long Beach, CA - Long Beach
- VA San Diego Healthcare System, San Diego, CA - San Diego
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL - Gainesville
- Miami VA Healthcare System, Miami, FL - Miami
- Orlando VA Medical Center, Orlando, FL - Orlando
- James A. Haley Veterans' Hospital, Tampa, FL - Tampa
Arizona
- Phoenix VA Health Care System, Phoenix, AZ - Phoenix
Arkansas
- Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR - Little Rock
Colorado
- VA Eastern Colorado Health Care System, Denver, CO - Denver
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
District of Columbia
- Washington DC VA Medical Center, Washington, DC - Washington D.C.
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50,126 participants |
| Start Date | 2012-04-30 |
| Est. Completion | 2028-12-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01239082
The ClinicalTrials.gov registry entry for NCT01239082 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 50,126 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,375-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (3546% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Colonoscopy is the first listed.
NCT01239082 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01239082 about?
NCT01239082 is a clinical study titled "Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM)". Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled trials that screening using fecal occult blood testing (FOBT) reduces CRC mortality by 13-33%. While the...
What is the current status of trial NCT01239082?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 50,126 participants. The study started on 2012-04-30. Estimated completion is 2028-12-01.
What conditions does trial NCT01239082 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT01239082?
The interventions under investigation include: Colonoscopy (PROCEDURE), FIT (PROCEDURE).
Who is sponsoring clinical trial NCT01239082?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01239082 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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