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A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis

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ClinicalTrials.gov Identifier: NCT04677998
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborators:
Leiden University Medical Center
The Netherlands Cancer Institute
St Mark's Hospital Foundation
Hospital Clinic of Barcelona
Hôpital Edouard Herriot
Maria Sklodowska-Curie National Research Institute of Oncology
Hospital General Universitario de Alicante
University Medical Center Mainz
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Information provided by (Responsible Party):
Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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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)

Condition or disease Intervention/treatment
Familial Adenomatous Polyposis Procedure: Personalized surveillance and intervention protocol

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Groups and Cohorts
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Group/Cohort Intervention/treatment
Personalized surveillance and intervention protocol Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Advanced neoplasia [ Time Frame: Up to 5 years ]
    Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer


Secondary Outcome Measures :
  1. Recurrences after different endoscopic intervention techniques [ Time Frame: Analysis at 2 years and 5 years ]
    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

  2. Feasibility of endoscopic interventions [ Time Frame: Analysis at 2 years and 5 years ]
    Incidence of lesions not amenable to endoscopic removal

  3. Accuracy optical diagnosis [ Time Frame: Analysis at 2 years and 5 years ]
    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.

  4. Complications [ Time Frame: Analysis at 2 years and 5 years ]
    Incidence of endoscopy related complications

  5. Surveillance burden [ Time Frame: Up to 5 years ]
    Surveillance burden (number of endoscopies for each patient)

  6. Surgery [ Time Frame: Up to 5 years ]
    Incidence of surgical interventions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with FAP treated at one of the participating centers will be assessed for 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677998


Locations
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Netherlands
Academic Medical Centre Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Contact: Evelien Dekker, MD, PhD    0031205661260    e.dekker@amc.uva.nl   
Sub-Investigator: Arthur Aelvoet, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Leiden University Medical Center
The Netherlands Cancer Institute
St Mark's Hospital Foundation
Hospital Clinic of Barcelona
Hôpital Edouard Herriot
Maria Sklodowska-Curie National Research Institute of Oncology
Hospital General Universitario de Alicante
University Medical Center Mainz
IRCCS Azienda Ospedaliero-Universitaria di Bologna
More Information
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Responsible Party: Prof. Evelien Dekker, MD, PhD, Prof. dr. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04677998    
Other Study ID Numbers: W20_181
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Endoscopic surveillance
Endoscopic interventions
Personalized care
Gastrointestinal neoplasia
Additional relevant MeSH terms:
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Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn