Familial Adenomatous PolyposisNCT04677998
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
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 personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP) 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 2020to Nov 2027
- 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: Patients with FAP treated at one of the participating centers will be assessed for eligibility.
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)
- Age 18 years or older
Who cannot join
- Endoscopic removal of all polyps with an indication for removal not possible/feasible
- Gastric or duodenal 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 personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)
Read the detailed description
Patients with FAP are not only at risk of developing colorectal adenomas but also at high risk of developing duodenal adenomas. In 30% to 92% of FAP patients duodenal adenomas are detected, with a lifetime risk approaching 100%. Of these duodenal adenomas, only a small proportion develops into duodenal cancer, with a prevalence of approximately 5-10% in FAP patients.
Endoscopic surveillance is nowadays the standard of care to prevent FAP patients from developing duodenal cancer. The severity of duodenal polyposis is assessed using the Spigelman classification system. This classification is based on the number, size, histology, and grade of dysplasia of the duodenal adenomas, resulting in a score varying from 0-IV, guiding surveillance intervals and treatment.
Concerns are rising on the accuracy of the Spigelman score as predictor for duodenal cancer, especially for ampullary cancer. Over the past years, multiple studies demonstrated limitations of this staging system including the fact that this classification does not adequately predict duodenal/ampullary cancer and does not guide endoscopic or surgical interventions. A clear endoscopic intervention protocol is needed, not only to prevent the development of cancer but also to prevent the need for duodenal surgery, since these surgical procedures are associated with high complication and mortality rates.
With this study, the investigators aim to evaluate a personalized surveillance and intervention protocol for the duodenum and stomach with the goal to prevent the 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, Personalized 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 3-6 months and 5 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 defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer
Measured: Up to 5 years
Secondary outcomes (6)
Recurrences after different endoscopic intervention techniques
Incidence of recurrences after endoscopic interventions after en bloc/piecemeal resection and different techniques such as cold snare polypectomy or endoscopic mucosal resection with or without lifting
Measured: Analysis at 2 years and 5 years
Feasibility of endoscopic interventions
Incidence of lesions not amenable to endoscopic removal
Measured: Analysis at 2 years and 5 years
Accuracy optical diagnosis
The ability of endoscopists to optically diagnose duodenal and gastric lesions. Sensitivity and specificity for optically diagnose high-grade dysplasia in the stomach and duodenum.
Measured: Analysis at 2 years and 5 years
Complications
Incidence of endoscopy related complications
Measured: Analysis at 2 years and 5 years
Surveillance burden
Surveillance burden (number of endoscopies for each patient)
Measured: Up to 5 years
Surgery
Incidence of surgical interventions
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 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (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, University Hospital, Bonn, Hvidovre University Hospital, M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677998
- Sponsor's protocol ID
- W20_181
- Status last verified
- Aug 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 Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT04677998
- Acronym / sponsor ID
- W20_181
- Conditions
- Familial Adenomatous Polyposis
- Keywords
- Endoscopic surveillance, Endoscopic interventions, Personalized 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, University Hospital, Bonn, Hvidovre University Hospital, M.D. Anderson Cancer Center
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (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 personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)
Detailed description
Patients with FAP are not only at risk of developing colorectal adenomas but also at high risk of developing duodenal adenomas. In 30% to 92% of FAP patients duodenal adenomas are detected, with a lifetime risk approaching 100%. Of these duodenal adenomas, only a small proportion develops into duodenal cancer, with a prevalence of approximately 5-10% in FAP patients.
Endoscopic surveillance is nowadays the standard of care to prevent FAP patients from developing duodenal cancer. The severity of duodenal polyposis is assessed using the Spigelman classification system. This classification is based on the number, size, histology, and grade of dysplasia of the duodenal adenomas, resulting in a score varying from 0-IV, guiding surveillance intervals and treatment.
Concerns are rising on the accuracy of the Spigelman score as predictor for duodenal cancer, especially for ampullary cancer. Over the past years, multiple studies demonstrated limitations of this staging system including the fact that this classification does not adequately predict duodenal/ampullary cancer and does not guide endoscopic or surgical interventions. A clear endoscopic intervention protocol is needed, not only to prevent the development of cancer but also to prevent the need for duodenal surgery, since these surgical procedures are associated with high complication and mortality rates.
With this study, the investigators aim to evaluate a personalized surveillance and intervention protocol for the duodenum and stomach with the goal to prevent the 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
- Patients with FAP treated at one of the participating centers will be assessed for eligibility.
Key inclusion criteria (2 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)
- Age 18 years or older
Key exclusion criteria (3 listed)
- Endoscopic removal of all polyps with an indication for removal not possible/feasible
- Gastric or duodenal 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 3-6 months and 5 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 defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer
6 secondary outcomes
Recurrences after different endoscopic intervention techniques
Time frame: Analysis at 2 years and 5 years
Feasibility of endoscopic interventions
Time frame: Analysis at 2 years and 5 years
Accuracy optical diagnosis
Time frame: Analysis at 2 years and 5 years
Complications
Time frame: Analysis at 2 years and 5 years
Surveillance burden
Time frame: Up to 5 years
Surgery
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 2 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.