Inflammatory Bowel DiseasesNCT05674773
Treatment Outcomes of Advanced Neoplasia in IBD
An observational study of Inflammatory Bowel Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Endoscopic or surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 189 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 May 2019to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: IBD patients with advanced neoplasia
Who may be able to join
- IBD (ulcerative colitis (UC), CD or IBD-unclassified (IBD-U))
- Histological diagnosis of colorectal AN
- Available treatment data
Who cannot join
- Familial CRC syndrome
- AN prior to IBD diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Endoscopic or surgical resection
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic or surgical resectionProcedure or surgery
endoscopic or surgical (partial, (sub)total, proctocolectomy) resection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Endoscopic or surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synchronous
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
Measured: up to 6 months
Metachronous (advanced) neoplasia
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
Measured: up to 30 years
Secondary outcomes (2)
All-cause mortality
All-cause mortality
Measured: up to 30 years
Associations with treatment choice
Clinical and disease characteristics associated with AN treatment choice
Measured: up to 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start21 May 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, Jeroen Bosch Ziekenhuis, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Frank Hoentjen, MD, PhD, Principal investigator, Radboudumc and University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674773
- Sponsor's protocol ID
- 2017-3219
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic and Surgical Treatment Outcomes of Colitis-associated Advanced Neoplasia: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05674773
- Acronym / sponsor ID
- 2017-3219
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, Jeroen Bosch Ziekenhuis, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, Erasmus Medical Center
- Study start
- 21 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients with advanced neoplasia | – | Procedure: Endoscopic or surgical resectionIBD patients with advanced neoplasia (high-grade dysplasia or colorectal cancer) treated with: * proctocolectomy * (sub)total colectomy * partial colectomy * endoscopic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- IBD patients with advanced neoplasia
Key inclusion criteria (3 listed)
- IBD (ulcerative colitis (UC), CD or IBD-unclassified (IBD-U))
- Histological diagnosis of colorectal AN
- Available treatment data
Key exclusion criteria (2 listed)
- Familial CRC syndrome
- AN prior to IBD diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic or surgical resectionendoscopic or surgical (partial, (sub)total, proctocolectomy) resection | Procedure or surgery | IBD patients with advanced neoplasia |
Primary outcome
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
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
2 secondary outcomes
All-cause mortality
Time frame: up to 30 years
Associations with treatment choice
Time frame: up to 30 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: Undecided. Data available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Hoentjen, MD, PhD principal investigator
Radboudumc and University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synchronous (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.