Status:

RECRUITING

Duodenal Polyposis Classification in FAP

Lead Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborating Sponsors:

IRCCS Ospedale San Raffaele

Conditions:

Duodenum Cancer

Familial Adenomatous Polyposis

Eligibility:

All Genders

18+ years

Brief Summary

Duodenal cancer is the leading cause of cancer-related mortality in patients with familial adenomatous polyposis (FAP), yet the current Spigelman staging system provides limited predictive accuracy fo...

Detailed Description

Duodenal cancers represent the leading cause of cancer-related mortality in individuals with familial adenomatous polyposis (FAP). While endoscopic surveillance is a critical component of duodenal can...

Eligibility Criteria

Inclusion

  • Confirmed germline diagnosis of FAP, as defined by genetic testing
  • Two or more upper gastrointestinal endoscopies
  • Complete documentation of all Spigelman classification variables at each endoscopic evaluation

Exclusion

  • Histological grading of duodenal polyps incomplete
  • Follow-up data were unavailable
  • Duodenal surgery before study baseline endoscopy

Key Trial Info

Start Date :

February 2 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 15 2030

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT07199127

Start Date

February 2 2018

End Date

January 15 2030

Last Update

September 30 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

IRCCS Ospedale San Raffaele

Milan, MI, Italy, 20129

2

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20133