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NCT01710215 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 5,999
- Enrollment target
NCT01710215 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 5,999 participants.
The verdict
NCT01710215, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 5,999 participants
- Enrollment target
Study Summary
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the entire screening process continuum. Modeling studies suggest benefits and harms of colonoscopy and stool blood test strategies are similar, but generally assume 100% participation and subsequent clinically appropriate follow up--something never achieved in clinical practice. Comparative effectiveness studies of testing strategies, including comparisons of specific tests and approaches to optimizing effective test use, are necessary. Safety-net health systems care for populations at increased risk for adverse CRC outcomes, such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets must resolve the uncertainty regarding the most effective screening strategy. The investigators will conduct a system-level, randomized comparative effectiveness trial of the benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age 50-64 years, who are not up-to-date with CRC screening, served by a large safety net health system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual mailed invitation outreach (including a test kit), and a centralized process to promote participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed invitation outreach, and a centralized process to promote participation and complete clinical follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at primary care visits. The primary measure of benefit will be an outcome measure that summarizes patient-specific effective screening successes. The primary measure of harm will be screening non-participation. The primary measure of cost will be cost per-patient effect
Interventions
- OTHER FIT Screening Strategy
- OTHER Colon Screening Strategy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,999 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01710215
The ClinicalTrials.gov registry entry for NCT01710215 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5,999 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FIT Screening Strategy is the first listed.
NCT01710215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01710215 about?
NCT01710215 is a clinical study titled "Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies". Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death can be reduced by screening. However, there is uncertainty as to which screening strategy is most clinically and cost-effective from a population perspective where the aim is to optimize completion of the en...
What is the current status of trial NCT01710215?
This trial is currently completed. It is a NA study. The enrollment target is 5,999 participants. The study started on 2013-04. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01710215?
The interventions under investigation include: FIT Screening Strategy (OTHER), Colon Screening Strategy (OTHER).
Who is sponsoring clinical trial NCT01710215?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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