Treatment Outcomes of Advanced Neoplasia in IBD

December 29, 2022 updated by: Radboud University Medical Center

Endoscopic and Surgical Treatment Outcomes of Colitis-associated Advanced Neoplasia: a Multicenter Cohort Study

In this study, we aimed to (1) compare cumulative incidences of synchronous and metachronous colorectal neoplasia as well as mortality following AN in CD and UC patients who underwent proctocolectomy, (sub)total colectomy, partial colectomy or endoscopic resection, and (2) to determine factors associated with AN treatment choice.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In this retrospective multicenter cohort study, using PALGA (the Dutch nationwide pathology databank), partial colectomy yielded a similar metachronous neoplasia risk compared to (sub)total colectomy after treatment of advanced neoplasia in inflammatory bowel disease. High metachronous neoplasia rates after endoscopic resection underline the importance of strict subsequent endoscopic surveillance.

Study Type

Observational

Enrollment (Actual)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

IBD patients with advanced neoplasia

Description

Inclusion Criteria:

  • IBD (ulcerative colitis (UC), CD or IBD-unclassified (IBD-U))
  • Histological diagnosis of colorectal AN
  • Available treatment data

Exclusion Criteria:

  • Familial CRC syndrome
  • AN prior to IBD diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IBD patients with advanced neoplasia

IBD patients with advanced neoplasia (high-grade dysplasia or colorectal cancer) treated with:

  • proctocolectomy
  • (sub)total colectomy
  • partial colectomy
  • endoscopic resection
Procedure: Endoscopic or surgical resection
endoscopic or surgical (partial, (sub)total, proctocolectomy) resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Synchronous
Time Frame: up to 6 months
defined as co-existence of two or more neoplastic colorectal lesions detected in the initial resection specimen or up to 6 months after treatment of the index lesion, categorized in (a) any neoplasia (independent of grade) and (b) only AN
up to 6 months
Metachronous (advanced) neoplasia
Time Frame: up to 30 years
defined as colorectal neoplasia detected >6 months after treatment of index AN, categorized in (a) any neoplasia (independent of grade) and (b) only AN, including the impact of IBD type
up to 30 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: up to 30 years
All-cause mortality
up to 30 years
Associations with treatment choice
Time Frame: up to 30 years
Clinical and disease characteristics associated with AN treatment choice
up to 30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

University Medical Center Groningen
Erasmus Medical Center
Amsterdam UMC, location VUmc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rijnstate Hospital
Jeroen Bosch Ziekenhuis

Investigators

  • Principal Investigator: Frank Hoentjen, MD, PhD, Radboudumc and University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 29, 2022

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-3219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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