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.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Spain
Complexo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Contact Information
Primary
Joaquín Cubiella, MD PhD
joaquin.cubiella.fernandez@sergas.es
0034988385824
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2035-06
Participants
Target number of participants: 3788
Treatments
Experimental: Group I
Annual FIT surveillance
Active_comparator: Group II
Endoscopic surveillance
Related Therapeutic Areas
Sponsors
Leads: Fundacin Biomedica Galicia Sur

This content was sourced from clinicaltrials.gov