Comparing fecal tests to endoscopic surveillance for colorectal cancer screening
Polyprev Study: Randomized, Multicenter, Controlled Trial Comparing Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.
This study is testing whether a simple stool test can be as effective as regular colonoscopies for preventing colorectal cancer in people aged 50 to 65 who are at high risk after having advanced polyps removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3788 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | Fundacin Biomedica Galicia Sur Academic / other |
| Locations | 1 site (Ourense) |
| Trial ID | NCT04967183 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of fecal immunochemical tests (FIT) compared to endoscopic surveillance in patients who have had advanced adenomas removed. The study will involve participants aged 50 to 65 years who have undergone colorectal cancer screening and have been identified as high-risk due to the presence of advanced lesions. By randomizing participants to either annual FIT or endoscopic surveillance, the trial seeks to determine the 10-year incidence of colorectal cancer in both groups. The goal is to assess whether FIT can serve as a non-inferior alternative to invasive colonoscopy, potentially reducing the number of procedures and associated costs.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 65 years with at least one advanced adenoma or multiple non-advanced adenomas that have been completely resected.
Not a fit: Patients with a personal history of colorectal cancer or significant hereditary predispositions to the disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more cost-effective screening option for colorectal cancer.
How similar studies have performed: Previous studies have indicated that fecal immunochemical tests may offer higher sensitivity and specificity for colorectal cancer detection compared to traditional endoscopic methods, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals aged 50 to 65 years. 2. Individuals with at least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or ≥ 10mm), and / or at least three non-advanced adenomas detected and resected completely within the population-based CRC screening program. Exclusion Criteria: 1. Personal history of CRC. 2. Colonic lesion ≥10mm resected without histological diagnosis. 3. More than 10 adenomas in baseline colonoscopy. 4. Serrated polyposis syndrome. 5. Two or more first-degree relatives with CRC. 6. Hereditary predisposition to CRC. 7. Relevant comorbidity with life expectancy inferior to 5 years. 8. Colonoscopy with incomplete mucosal examination. 9. Incomplete resection of baseline lesions. 10. Non-acceptance after reading the informed consent.
Where this trial is running
Ourense
- Complexo Hospitalario Universitario de Ourense — Ourense, Spain (Recruiting)
Study contacts
- Study coordinator: Joaquín Cubiella, MD PhD
- Email: joaquin.cubiella.fernandez@sergas.es
- Phone: 0034988385824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.