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NCT05536713 · ClinicalTrials.gov registry record
Understanding Patient Preference on Colorectal Cancer Screening Options
A clinical trial, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- 297
- Enrollment target
NCT05536713: Completed study, sponsored by Milton S. Hershey Medical Center.
NCT05536713 is a clinical trial that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 297 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05536713 has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- 297 participants
- Enrollment target
Study Summary
Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. There are different well-established CRC screening modalities, including invasive and non-invasive, which detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness, perception of discomfort and embarrassment, logistical challenges, cost, and potential risks. Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. A key to enhancing screening participation is patient acceptance of the testing method. A blood-based screening test presents an opportunity to overcome some challenging barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be part of a standard medical office appointment for a wellness check or scheduled visits to manage chronic illnesses and be completed at the point of care. This study will examine patient preference to use a blood-based screening test and compliance with CRC screening recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is particularly poor among medically underserved populations, and most of these vulnerable individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a blood-based screening test at FQHCs has the potential to improve CRC screening uptake and adherence and improve health disparities in medically underserved populations. This study seeks to answer the following four questions: 1) What is the acceptability of a blood-based screening as an alternative for patients who failed to complete
Primary Outcome
Number of unique patients who enrolled in the study and received a blood-based screening test order from their providers
Interventions
- DEVICE Guardant SHIELD blood-based colorectal cancer screening test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2025-12-18 |
What the finished NCT05536713 record still lists
NCT05536713 is an observational study that tracks outcomes without assigning an intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Guardant SHIELD blood-based colorectal cancer screening test is the first listed.
NCT05536713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05536713 about?
NCT05536713 is a clinical study titled "Understanding Patient Preference on Colorectal Cancer Screening Options". Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-relat...
What is the current status of trial NCT05536713?
This trial is currently completed. The enrollment target is 297 participants. The study started on 2023-02-09. Estimated completion is 2025-12-18.
What interventions are being tested in trial NCT05536713?
The interventions under investigation include: Guardant SHIELD blood-based colorectal cancer screening test (DEVICE).
Who is sponsoring clinical trial NCT05536713?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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