Clinical trial · Observational
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
NCT04678011CI-TRIAL-00103879recruitingClinicalTrials.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 personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.
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 (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.
Secondary outcomes (6)
- measure
- Characteristics polyps
- timeFrame
- Up to 5 years
- description
- Incidence and characteristics of polyps detected/removed in patients with IRA/ISA and IPAA
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) * Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA * Age 18 years or older Exclusion Criteria: * Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies * Cancer at baseline endoscopy * Need for surgery
References
Publications (0)
Data not yet available
No reference posted for this study.