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History of Changes for Study: NCT02319928
European Polyp Surveillance Trial (EPoS)
Latest version (submitted January 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 15, 2014 None (earliest Version on record)
2 December 26, 2014 Conditions and Study Status
3 November 23, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 June 26, 2018 Study Status, Contacts/Locations, Outcome Measures and Conditions
5 July 7, 2019 Contacts/Locations and Study Status
6 December 16, 2019 Study Status, Study Design and Study Description
7 January 11, 2021 Recruitment Status, Study Status and Contacts/Locations
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Study NCT02319928
Submitted Date:  December 15, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: AEG-EPOS-1
Brief Title: European Polyp Surveillance Trial (EPoS)
Official Title: Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2014
Overall Status: Not yet recruiting
Study Start: February 2015
Primary Completion: December 2028 [Anticipated]
Study Completion: December 2028 [Anticipated]
First Submitted: December 15, 2014
First Submitted that
Met QC Criteria:
December 15, 2014
First Posted: December 18, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 15, 2014
Last Update Posted: December 18, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Asociación Española de Gastroenterología
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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 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.

Detailed Description:
Open or close this module Conditions
Conditions: "Colonic Polyps" "Colorectal Cancer"
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Investigator)
Allocation: Randomized
Enrollment: 28000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Procedure: Colonoscopy
Experimental: Long-term surveillance
Long-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas.
Procedure: Colonoscopy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Colorectal cancer incidence
[ Time Frame: 10 years ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 74 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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).
Open or close this module Contacts/Locations
Central Contact Person: Annike Sunde, MD
Email: annike.sunde@frontier-science.co.uk
Study Officials: Rodrigo Jover, MD
Principal Investigator
Hospital General Universitario de Alicante
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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