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European Polyp Surveillance Trial (EPoS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319928
Recruitment Status : Active, not recruiting
First Posted : December 18, 2014
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Asociación Española de Gastroenterología

Tracking Information
First Submitted Date  ICMJE December 15, 2014
First Posted Date  ICMJE December 18, 2014
Last Update Posted Date January 12, 2021
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
Colorectal cancer incidence [ Time Frame: 10 years ]
development of new colorectal cancer cases in the different arms of the trial
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
Colorectal cancer incidence [ Time Frame: 10 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE European Polyp Surveillance Trial
Official Title  ICMJE Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Procedure: Colonoscopy
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Colonoscopy
  • Experimental: Long-term surveillance
    Long-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas.
    Intervention: Procedure: Colonoscopy
Publications * Jover R, Bretthauer M, Dekker E, Holme Ø, Kaminski MF, Løberg M, Zauber AG, Hernán MA, Lansdorp-Vogelaar I, Sunde A, McFadden E, Castells A, Regula J, Quintero E, Pellisé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2019)
20000
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2014)
28000
Estimated Study Completion Date  ICMJE December 2028
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02319928
Other Study ID Numbers  ICMJE AEG-EPOS-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Asociación Española de Gastroenterología
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Asociación Española de Gastroenterología
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Jover, MD Hospital General Universitario de Alicante
Principal Investigator: Michael Bretthauer, MD University of Oslo
PRS Account Asociación Española de Gastroenterología
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP