Familial Adenomatous PolyposisNCT04678011
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
An observational study of Familial Adenomatous Polyposis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- Personalized surveillance and intervention protocol
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Nov 2021to Nov 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with FAP treated at one of the participating centres.
Who may be able to join
- Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (>100 colorectal adenomas in combination with a positive family history of FAP)
- Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA
- Age 18 years or older
Who cannot join
- Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
- Cancer at baseline endoscopy
- Need for surgery
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
MD Anderson
Houston, Texas, 77030
Annie Lincoln, +1 919 923 4430, aglincoln@mdanderson.org
Luigi Ricciardiello
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Centre
Amsterdam, North Holland, 1105AZ
Evelien Dekker, MD, PhD, 0031205661260, e.dekker@amc.uva.nl
Arthur Aelvoet, MD
About this study
The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.
Read the detailed description
Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP develop colorectal cancer at a median age of 35-45 years. To prevent colorectal cancer in patients with FAP, prophylactic colorectal surgery is performed. The preferred surgical procedures for FAP are a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) or a subtotal colectomy with ileorectal anastomosis (IRA) or ileosigmoidal anastomosis (ISA).
After both types of prophylactic colorectal surgery, subtotal colectomy with IRA/ISA or proctocolectomy with IPAA, patients will require life-long surveillance because disease progression and development of new adenomas in retained rectum, pouch or residual rectal cuff will occur.
The 10-years risk of developing one or more adenomas in the rectum after IRA is 100% compared to 33% in the pouch after IPAA. The risk of developing rectal cancer after IRA was found to be 9% and 11% in two large studies with a median follow-up of 12.8 and 15 years, respectively. One study showed that the 10-years risk of developing a carcinoma in the pouch was 1%. As patients are usually operated at a young age, and nowadays have a long life-expectancy, the actual cumulative life-time risk will presumably be higher.
The recently published ESGE (European Society of Gastrointestinal Endoscopy) polyposis guideline recommends a one to two yearly endoscopic surveillance interval after prophylactic colorectal surgery in FAP, both for patients that underwent IRA/ISA and IPAA, with removal of all polyps >5mm. This recommendation is based on expert-opinion, since no studies have been reported comparing the efficacy and safety of different surveillance intervals. No advices are provided on which patients will benefit from which surveillance interval.
With the proposed study, the investigators aim to provide evidence for personalized endoscopic surveillance for patients with FAP that have undergone (procto)colectomy with construction of an IRA/ISA or IPAA with the goal to prevent development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.
- Conditions
- Familial Adenomatous Polyposis
- Being tested
- Personalized surveillance and intervention protocol
- Keywords
- Endoscopic surveillance, Endoscopic interventions, Personalised care, Gastrointestinal neoplasia
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized surveillance and intervention protocolProcedure or surgery
This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 6 months and 2 years, depending on severity of polyposis and performed endoscopic interventions.
| Study group | Role | What they receive |
|---|---|---|
| Personalized surveillance and intervention protocol | Not described Receives: Procedure: Personalized surveillance and intervention protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced neoplasia
Incidence of advanced neoplasia (advanced adenoma and cancer). An advanced adenoma is defined as size ≥ 10mm and/or high-grade dysplasia. This surveillance and intervention protocol will be considered successful when the incidence of advanced neoplasia is less than 5% after a study period of 5 years.
Measured: Up to 5 years
Secondary outcomes (6)
Characteristics polyps
Incidence and characteristics of polyps detected/removed in patients with IRA/ISA and IPAA
Measured: Up to 5 years
Radicality of different endoscopic intervention techniques
Rate of radical endoscopic interventions
Measured: Up to 5 years
Feasibility endoscopic interventions
Incidence of lesions not amenable to endoscopic removal
Measured: Up to 5 years
Surgical interventions
Incidence of surgical interventions
Measured: Up to 5 years
Surveillance burden
Surveillance burden (number of endoscopies per patient)
Measured: Up to 5 years
Complications
Incidence of endoscopy related complications
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start24 Nov 2021
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, The Netherlands Cancer Institute, St Mark's Hospital Foundation, Hospital Clinic of Barcelona, Maria Sklodowska-Curie National Research Institute of Oncology, Hospital General Universitario de Alicante, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Radboud University Medical Center, Hvidovre University Hospital, M.D. Anderson Cancer Center, University Hospital, Bonn
- Responsible party
- Principal investigator, Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678011
- Sponsor's protocol ID
- W20_182
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2020
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
- ClinicalTrials.gov ID
- NCT04678011
- Acronym / sponsor ID
- W20_182
- Conditions
- Familial Adenomatous Polyposis
- Keywords
- Endoscopic surveillance, Endoscopic interventions, Personalised care, Gastrointestinal neoplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Leiden University Medical Center, The Netherlands Cancer Institute, St Mark's Hospital Foundation, Hospital Clinic of Barcelona, Maria Sklodowska-Curie National Research Institute of Oncology, Hospital General Universitario de Alicante, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Radboud University Medical Center, Hvidovre University Hospital, M.D. Anderson Cancer Center, University Hospital, Bonn
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Dec 2020 (actual)
- 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.
The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.
Detailed description
Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP develop colorectal cancer at a median age of 35-45 years. To prevent colorectal cancer in patients with FAP, prophylactic colorectal surgery is performed. The preferred surgical procedures for FAP are a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) or a subtotal colectomy with ileorectal anastomosis (IRA) or ileosigmoidal anastomosis (ISA).
After both types of prophylactic colorectal surgery, subtotal colectomy with IRA/ISA or proctocolectomy with IPAA, patients will require life-long surveillance because disease progression and development of new adenomas in retained rectum, pouch or residual rectal cuff will occur.
The 10-years risk of developing one or more adenomas in the rectum after IRA is 100% compared to 33% in the pouch after IPAA. The risk of developing rectal cancer after IRA was found to be 9% and 11% in two large studies with a median follow-up of 12.8 and 15 years, respectively. One study showed that the 10-years risk of developing a carcinoma in the pouch was 1%. As patients are usually operated at a young age, and nowadays have a long life-expectancy, the actual cumulative life-time risk will presumably be higher.
The recently published ESGE (European Society of Gastrointestinal Endoscopy) polyposis guideline recommends a one to two yearly endoscopic surveillance interval after prophylactic colorectal surgery in FAP, both for patients that underwent IRA/ISA and IPAA, with removal of all polyps >5mm. This recommendation is based on expert-opinion, since no studies have been reported comparing the efficacy and safety of different surveillance intervals. No advices are provided on which patients will benefit from which surveillance interval.
With the proposed study, the investigators aim to provide evidence for personalized endoscopic surveillance for patients with FAP that have undergone (procto)colectomy with construction of an IRA/ISA or IPAA with the goal to prevent development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized surveillance and intervention protocol | – | Procedure: Personalized surveillance and intervention protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with FAP treated at one of the participating centres.
Key inclusion criteria (3 listed)
- Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (>100 colorectal adenomas in combination with a positive family history of FAP)
- Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA
- Age 18 years or older
Key exclusion criteria (3 listed)
- Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
- Cancer at baseline endoscopy
- Need for surgery
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 |
|---|---|---|
| Personalized surveillance and intervention protocolThis study uses one arm. Participants will undergo endoscopic surveillance with intervals between 6 months and 2 years, depending on severity of polyposis and performed endoscopic interventions. | Procedure or surgery | Personalized surveillance and intervention protocol |
Primary outcome
Advanced neoplasia
Time frame: Up to 5 years
Incidence of advanced neoplasia (advanced adenoma and cancer). An advanced adenoma is defined as size ≥ 10mm and/or high-grade dysplasia. This surveillance and intervention protocol will be considered successful when the incidence of advanced neoplasia is less than 5% after a study period of 5 years.
6 secondary outcomes
Characteristics polyps
Time frame: Up to 5 years
Radicality of different endoscopic intervention techniques
Time frame: Up to 5 years
Feasibility endoscopic interventions
Time frame: Up to 5 years
Surgical interventions
Time frame: Up to 5 years
Surveillance burden
Time frame: Up to 5 years
Complications
Time frame: Up to 5 years
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 23 Feb 2026.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Adenomatous Polyposis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
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 3 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced neoplasia (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.