ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02319928
Recruitment Status : Recruiting
First Posted : December 18, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Asociación Española de Gastroenterología

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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: Colonoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Colorectal cancer incidence [ Time Frame: 10 years ]
    development of new colorectal cancer cases in the different arms of the trial



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

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


Contacts
Contact: Janette Mackay, MD janette.mackay@frontier-science.co.uk

Locations
Spain
Hospital General Universitario de Alicante Recruiting
Alicante, Spain, 03010
Contact: Rodrigo Jover, MD    +34607165995    rodrigojover@gmail.com   
Sponsors and Collaborators
Asociación Española de Gastroenterología
Investigators
Principal Investigator: Rodrigo Jover, MD Hospital General Universitario de Alicante

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Asociación Española de Gastroenterología
ClinicalTrials.gov Identifier: NCT02319928     History of Changes
Other Study ID Numbers: AEG-EPOS-1
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases