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NCT03598166 · ClinicalTrials.gov registry record · NA
Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion
A NA study of Colorectal Cancer, sponsored by Peter S. Liang, MD MPH.
- Completed
- Registry status
- NA
- Development phase
- 359
- Enrollment target
- 1
- Study location
NCT03598166: Completed NA study of Colorectal Cancer, sponsored by Peter S. Liang, MD MPH.
NCT03598166 is a NA study of Colorectal Cancer that has completed, run by Peter S. Liang, MD MPH. The registered enrollment target is 359 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598166, a NA study of Colorectal Cancer, has completed, sponsored by Peter S. Liang, MD MPH.
- COMPLETED
- Registry status
- NA
- Development phase
- 359 participants
- Enrollment target
- 1
- Study location
Study Summary
Objectives: Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenient or unacceptable for a variety of reasons. There is an unmet need for a non-invasive test that does not require bowel preparation or handling stool, and the Septin9 DNA blood test may be an alternative for those individuals who would otherwise remain unscreened. Aims: Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical Center * Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test who undergo diagnostic colonoscopy * Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about colorectal cancer screening and testing options We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT will accept the blood test. We hypothesize this will be driven by the convenience of the blood test. Methods: This will be randomized controlled trial of individuals who have refused colonoscopy and FIT within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter and telephone call. The intervention group will also be invited to participate in the blood test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total n=360).
Primary Outcome
Percentage of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Septin9
Study Locations (1)
New York
- VA New York Harbor Health Care System - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 359 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2020-12-31 |
| Phase | NA |
What the finished NCT03598166 record still lists
NCT03598166 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Septin9 is the first listed.
NCT03598166 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03598166 about?
NCT03598166 is a clinical study titled "Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion". Objectives: Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenien...
What is the current status of trial NCT03598166?
This trial is currently completed. It is a NA study. The enrollment target is 359 participants. The study started on 2018-10-11. Estimated completion is 2020-12-31.
What conditions does trial NCT03598166 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT03598166?
The interventions under investigation include: Septin9 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03598166?
This trial is sponsored by Peter S. Liang, MD MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03598166 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03598166's enrollment target sits among peer trials
359 100th of 381 higher than 282 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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