European Polyp Surveillance Trial (EPoS)
Primary Purpose
Colorectal Neoplasms
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Lack of consent
- 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
- Incomplete colonoscopy
- Incomplete endoscopic excision of polyps
- Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- Inflammatory bowel disease
- History of surgical colon resection for any reason
- Severe co-morbidity with reduced life expectancy (NYHA 3-4)
- On-going cytotoxic treatment or radiotherapy for malignant disease
- Long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
Sites / Locations
- Hospital General Universitario de Alicante
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Short-term surveillance
Long-term surveillance
Arm Description
Short-term surveillance. Colonoscopy at 5+10 years in low-risk adenomas or 3+5 years in high-risk adenomas.
Long-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas.
Outcomes
Primary Outcome Measures
Colorectal cancer incidence
development of new colorectal cancer cases in the different arms of the trial
Secondary Outcome Measures
Full Information
NCT ID
NCT02319928
First Posted
December 15, 2014
Last Updated
January 11, 2021
Sponsor
Asociación Española de Gastroenterología
1. Study Identification
Unique Protocol Identification Number
NCT02319928
Brief Title
European Polyp Surveillance Trial
Acronym
EPoS
Official Title
Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asociación Española de Gastroenterología
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short-term surveillance
Arm Type
Active Comparator
Arm Description
Short-term surveillance. Colonoscopy at 5+10 years in low-risk adenomas or 3+5 years in high-risk adenomas.
Arm Title
Long-term surveillance
Arm Type
Experimental
Arm Description
Long-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Primary Outcome Measure Information:
Title
Colorectal cancer incidence
Description
development of new colorectal cancer cases in the different arms of the trial
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Lack of consent
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
Incomplete colonoscopy
Incomplete endoscopic excision of polyps
Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
Inflammatory bowel disease
History of surgical colon resection for any reason
Severe co-morbidity with reduced life expectancy (NYHA 3-4)
On-going cytotoxic treatment or radiotherapy for malignant disease
Long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Jover, MD
Organizational Affiliation
Hospital General Universitario de Alicante
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Bretthauer, MD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
36307178
Citation
Juul FE, Garborg K, Nesbakken E, Loberg M, Wieszczy P, Cubiella J, Kalager M, Kaminski MF, Erichsen R, Adami HO, Ferlitsch M, Furholm SKB, Zauber AG, Quintero E, Bugajski M, Holme O, Dekker E, Jover R, Bretthauer M. Rates of repeated colonoscopies to clean the colon from low-risk and high-risk adenomas: results from the EPoS trials. Gut. 2023 May;72(5):951-957. doi: 10.1136/gutjnl-2022-327696. Epub 2022 Oct 28.
Results Reference
derived
PubMed Identifier
27042931
Citation
Jover R, Bretthauer M, Dekker E, Holme O, Kaminski MF, Loberg M, Zauber AG, Hernan MA, Lansdorp-Vogelaar I, Sunde A, McFadden E, Castells A, Regula J, Quintero E, Pellise M, Senore C, Kalager M, Dinis-Ribeiro M, Emilsson L, Ransohoff DF, Hoff G, Adami HO. Rationale and design of the European Polyp Surveillance (EPoS) trials. Endoscopy. 2016 Jun;48(6):571-8. doi: 10.1055/s-0042-104116. Epub 2016 Apr 4.
Results Reference
derived
Learn more about this trial
European Polyp Surveillance Trial
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