European Polyp Surveillance Trial (EPoS)
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|ClinicalTrials.gov Identifier: NCT02319928|
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : June 28, 2018
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 27,500 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Procedure: Colonoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2028|
|Estimated Study Completion Date :||December 2028|
Active Comparator: Short-term surveillance
Short-term surveillance. Colonoscopy at 5+10 years in low-risk adenomas or 3+5 years in high-risk adenomas.
Experimental: Long-term surveillance
Long-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas.
- Colorectal cancer incidence [ Time Frame: 10 years ]development of new colorectal cancer cases in the different arms of the trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319928
|Contact: Janette Mackay, MDfirstname.lastname@example.org|
|Hospital General Universitario de Alicante||Recruiting|
|Alicante, Spain, 03010|
|Contact: Rodrigo Jover, MD +34607165995 email@example.com|
|Principal Investigator:||Rodrigo Jover, MD||Hospital General Universitario de Alicante|