A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
NCT ID: NCT04677998
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2020-11-24
2025-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Personalized surveillance and intervention protocol
Personalized surveillance and intervention protocol
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.
Interventions
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Personalized surveillance and intervention protocol
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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
Exclusion Criteria
* Gastric or duodenal cancer at baseline endoscopy
* Need for surgery
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
The Netherlands Cancer Institute
OTHER
St Mark's Hospital Foundation
OTHER
Hospital Clinic of Barcelona
OTHER
Hôpital Edouard Herriot
OTHER
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER
Hospital General Universitario de Alicante
OTHER
University Medical Center Mainz
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Evelien Dekker, MD, PhD
Prof. dr. Evelien Dekker, MD, PhD
Locations
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Academic Medical Centre
Amsterdam, North Holland, Netherlands
Countries
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Facility Contacts
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Evelien Dekker, MD, PhD
Role: primary
Other Identifiers
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W20_181
Identifier Type: -
Identifier Source: org_study_id