Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.
Recruiting · NCT04967183 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundacin Biomedica Galicia Sur
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesions is detected, it is recommended to perform endoscopic surveillance with different intervals between explorations. Although the reduction in CRC incidence, endoscopic surveillance is producing a considerable increase in the number of colonoscopies. However, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non inferior alternative to endoscopic surveillance. Based on this hypothesis, the research group have designed a randomized clinical trial within the population CRC screening programs to compare FIT surveillance to endoscopic surveillance in patients with advanced lesions resected.
Who can take part
Inclusion criteria
- Individuals aged 50 to 65 years.
- 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
- Personal history of CRC.
- Colonic lesion ≥10mm resected without histological diagnosis.
- More than 10 adenomas in baseline colonoscopy.
- Serrated polyposis syndrome.
- Two or more first-degree relatives with CRC.
- Hereditary predisposition to CRC.
- Relevant comorbidity with life expectancy inferior to 5 years.
- Colonoscopy with incomplete mucosal examination.
- Incomplete resection of baseline lesions.
- Non-acceptance after reading the informed consent.
Where it is running
1 location listed.
- Complexo Hospitalario Universitario de Ourense - Ourense, Spain