Clinical trial · Observational
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
NCT04677998CI-TRIAL-00103846recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized surveillance and intervention protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Personalized surveillance and intervention protocol
- interventionNames
- Procedure: Personalized surveillance and intervention protocol
Primary outcomes (1)
- measure
- Advanced neoplasia
- timeFrame
- Up to 5 years
- description
- Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer
Secondary outcomes (6)
- measure
- Recurrences after different endoscopic intervention techniques
- timeFrame
- Analysis at 2 years and 5 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Endoscopic removal of all polyps with an indication for removal not possible/feasible * Gastric or duodenal cancer at baseline endoscopy * Need for surgery
References
Publications (0)
Data not yet available
No reference posted for this study.