- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05674773
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
-
-
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:
|
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.
Collaborators
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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