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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
| The Netherlands Cancer Institute | OTHER |
| St Mark's Hospital Foundation | OTHER |
| Hospital Clinic of Barcelona |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized surveillance and intervention protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized surveillance and intervention protocol | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Advanced neoplasia | Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Analysis at 2 years and 5 years |
| Feasibility of endoscopic interventions |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with FAP treated at one of the participating centers will be assessed for eligibility.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
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| OTHER |
| Maria Sklodowska-Curie National Research Institute of Oncology | OTHER |
| Hospital General Universitario de Alicante | OTHER |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| Radboud University Medical Center | OTHER |
| University Hospital, Bonn | OTHER |
| Hvidovre University Hospital | OTHER |
| M.D. Anderson Cancer Center | OTHER |
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Incidence of lesions not amenable to endoscopic removal |
| 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. | Analysis at 2 years and 5 years |
| Complications | Incidence of endoscopy related complications | Analysis at 2 years and 5 years |
| Surveillance burden | Surveillance burden (number of endoscopies for each patient) | Up to 5 years |
| Surgery | Incidence of surgical interventions | Up to 5 years |
| Academic Medical Centre | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
|
| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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