Clinical trial NCT04677998: A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Official title: A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Familial Adenomatous Polyposis
Keywords: Endoscopic surveillance
Endoscopic interventions
Personalized care
Gastrointestinal neoplasia
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: The Netherlands Cancer Institute
name: St Mark's Hospital Foundation
name: Hospital Clinic of Barcelona
name: Hôpital Edouard Herriot
name: Maria Sklodowska-Curie National Research Institute of Oncology
name: Hospital General Universitario de Alicante
name: University Medical Center Mainz
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
First posted: 2020-12-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with FAP treated at one of the participating centers will be assessed for eligibility.

Brief 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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Advanced neoplasia
timeFrame: Up to 5 years
Secondary outcomes:
measure: Recurrences after different endoscopic intervention techniques
timeFrame: Analysis at 2 years and 5 years
measure: Feasibility of endoscopic interventions
timeFrame: Analysis at 2 years and 5 years
measure: Accuracy optical diagnosis
timeFrame: Analysis at 2 years and 5 years
measure: Complications
timeFrame: Analysis at 2 years and 5 years
measure: Surveillance burden
timeFrame: Up to 5 years
measure: Surgery
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
state: Noord-Holland
Study officials:
References: