Actively Recruiting

Phase Not Applicable
Age: 50Years - 65Years
All Genders
Healthy Volunteers
NCT04967183

Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

Led by Fundacin Biomedica Galicia Sur · Updated on 2024-02-28

3788

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Polyprev: Study to Compare Fecal Immunochemical Test With Endoscopic Surveillance After Advanced Adenoma Resection in Fecal Immunochemical Test Colorectal Cancer Screening Programs.

Who Can Participate

Age: 50Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 50 to 65 years
  • At least one advanced adenoma (tubulovillous or villous histology, high grade dysplasia or 210mm), and/or at least three non-advanced adenomas completely removed within CRC screening programs
Not Eligible

You will not qualify if you...

  • Personal history of colorectal cancer
  • Colonic lesion 10mm or larger removed without histological diagnosis
  • More than 10 adenomas found in baseline colonoscopy
  • Serrated polyposis syndrome
  • Two or more first-degree relatives with colorectal cancer
  • Hereditary predisposition to colorectal cancer
  • Serious illnesses with life expectancy under 5 years
  • Colonoscopy with incomplete mucosal examination
  • Incomplete removal of baseline lesions
  • Not agreeing to participate after informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Complexo Hospitalario Universitario de Ourense

Ourense, Spain, 32002

Actively Recruiting

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Research Team

J

Joaquín Cubiella, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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