NCT02319928Active, not recruiting
European Polyp Surveillance Trial
Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas
Source: ClinicalTrials.gov · Last updated 12 Jan 2021
Brief summary (registry, in English)
This protocol describes the epos (ancient greek (Επος) for "story") of a group of related clinical trials aiming at addressing one of the most important unsolved challenges in the prevention of colorectal cancer (one of our major cancer killers); the surveillance of patients with premalignant polyps in the large bowel. This project is timely because large scale colorectal cancer screening programmes are currently rolled out in most Western countries. These programmes are diagnosing large numbers of individuals with premalignant polyps (adenomas and serrated polyps). This creates both a diagnostic and resource dilemma, because the optimal surveillance strategy for these individuals to reduce future cancer risk is currently unknown.. The EPoS trials will randomize or register more than 20,000 individuals in different European countries to different surveillance colonoscopy intervals to disentangle the most effective and cost-effective surveillance strategy for the population. Subjects will be randomized according to their presenting polyp chracteristics The EPoS I trial randomizes patients with low-risk adenomas into 5 or 10-year surveillance; ; EPoS II randomizes patients with high-risk adenomas into 3 or 5-yearly surveillance ; EPoS III will include patients with serrated polyps in a one-arm study with surveillance after 5 and 10 years. The primary endpoint for all three trials is incidence of colorectal cancer after 10 years of follow-up. This EPoS trials are the largest in polyp surveillance ever conducted. They address a clinical problem affecting hundreds of thousand individuals in Europe and the US each year, it has a large size, and should thus provide definitive results.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20000 (estimated)
- First submitted
- 15 Dec 2014
- Start date
- Jun 2015
- Primary completion date
- Dec 2028
- Lead sponsor
- Asociación Española de Gastroenterología
- Diseases
- Colorectal cancer
- NCT number
- NCT02319928
What you commit to
- Study type: Interventional
- Planned participants: 20000
- From Jun 2015 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of CRC or adenomas
- History of serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure
- Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- Inflammatory bowel disease
- History of surgical colon resection for any reason
- On-going cytotoxic treatment or radiotherapy for malignant disease
Other
- Lack of consent
- Incomplete colonoscopy
- Incomplete endoscopic excision of polyps
- Severe co-morbidity with reduced life expectancy (NYHA 3-4)
- Long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
Who the study is looking for
- Cecal intubation (preferably documented by images/videoof the apendiceal orifice and the ileocecal valve; but not required).
- Adequate colonic cleansing, with Boston Bowel Cleansing Score equal or higher than 2 points in all colonic segments.
- Complete excision of all polyps at baseline colonoscopy findings (as judged by the trial endoscopists).
Age in the registry: 40 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
Related publications
- Colonoscopy Intervals and Colorectal Cancer Incidence after Adenoma Removal.N Engl J Med · 2026 · PMID 42748427
This page is information, not medical advice. Discuss any trial with your doctor.