Colorectal NeoplasmsEPoSNCT02319928
European Polyp Surveillance Trial
A study testing Colonoscopy in people with Colorectal Neoplasms, run by Asociación Española de Gastroenterología at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas
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..
Read more
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Short-term surveillance | Active comparator | Short-term surveillance. Colonoscopy at 5+10 years in low-risk adenomas or 3+5 years in high-risk adenomas. Receives: Procedure: Colonoscopy |
| Long-term surveillance | Experimental | Long-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer incidence
development of new colorectal cancer cases in the different arms of the trial
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación Española de Gastroenterología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo Jover, MD, Principal investigator, Hospital General Universitario de AlicanteMichael Bretthauer, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319928
- Sponsor's protocol ID
- AEG-EPOS-1
- Acronym
- EPoS
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2014
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jover R, Bretthauer M, Cubiella J, Barry SJE, Macios A, Barnett L, Erichsen R, Kaminski MF, Adami HO, Holme O, Ijspeert J, Ferlitsch M, Dinis-Ribeiro M, Pellise M, Martinez-Roca A, Baile-Maxia S, de-Castro L, Bujanda L, Diez-Redondo P, Nilsen JAN, Nguyen HD, Bernklev L, Tilma J, Love US, Jaensch C, Pilonis ND, Szura M, Bialek A, van Berkel A, Spaander MCW, Ter Borg F, van Leerdam ME, Hernan MA, Regula J, Loberg M, Dekker E, Kalager M; EPoS Study Group. Colonoscopy Intervals and Colorectal Cancer Incidence after Adenoma Removal. N Engl J Med. 2026 Sep 17;395(11):1051-1061. doi: 10.1056/NEJMoa2603816.
PubMed 42748427Juul 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.
PubMed 36307178Jover 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.
PubMed 27042931
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Comparison Between Surveillance Intervals After Excision of Colonic Adenomas
- ClinicalTrials.gov ID
- NCT02319928
- Acronym / sponsor ID
- EPoS / AEG-EPOS-1
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Asociación Española de GastroenterologíaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term surveillance | Active comparator | Procedure: ColonoscopyShort-term surveillance. Colonoscopy at 5+10 years in low-risk adenomas or 3+5 years in high-risk adenomas. |
| Long-term surveillance | Experimental | Procedure: ColonoscopyLong-term surveillance. Colonoscopy at 10 years in low-risk adenomas or 5 years in high-risk adenomas. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy | Procedure or surgery | Long-term surveillance, Short-term surveillance |
Primary outcome
Colorectal cancer incidence
Time frame: 10 years
development of new colorectal cancer cases in the different arms of the trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Derived from this study: PubMed 42748427Jover R, Bretthauer M, Cubiella J, Barry SJE, Macios A, Barnett L, Erichsen R, Kaminski MF, Adami HO, Holme O, Ijspeert J, Ferlitsch M, Dinis-Ribeiro M, Pellise M, Martinez-Roca A, Baile-Maxia S, de-Castro L, Bujanda L, Diez-Redondo P, Nilsen JAN, Nguyen HD, Bernklev L, Tilma J, Love US, Jaensch C, Pilonis ND, Szura M, Bialek A, van Berkel A, Spaander MCW, Ter Borg F, van Leerdam ME, Hernan MA, Regula J, Loberg M, Dekker E, Kalager M; EPoS Study Group. Colonoscopy Intervals and Colorectal Cancer Incidence after Adenoma Removal. N Engl J Med. 2026 Sep 17;395(11):1051-1061. doi: 10.1056/NEJMoa2603816.
- Derived from this study: PubMed 36307178Juul 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.
- Derived from this study: PubMed 27042931Jover 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Jover, MD principal investigator
Hospital General Universitario de Alicante
Michael Bretthauer, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Colorectal Neoplasms, run by Asociación Española de Gastroenterología at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer incidence (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319928, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.