Crohn DiseaseNCT05174208
Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease
An observational study of Crohn Disease and Prognostic Model, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease, Prognostic Model, Radiomics
- What is being tested?
- CTE examination
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 20 Dec 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 2017-2020 CD patients in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University.
Who may be able to join
- patients with a confirmed diagnosis of CD; a follow-up more than 1 year; without previous CD-associated intestinal surgeries; complete data of CTE.
Who cannot join
- patients without a confirmed diagnosis of CD; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone CTE examination.
Trial locations and contacts
1 site in 1 country.
China1 site
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 501655
About this study
Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. We aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.
- Conditions
- Crohn Disease, Prognostic Model, Radiomics
- Being tested
- CTE examination
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTE examinationOther
each patients should have undergone CTE examination
| Study group | Role | What they receive |
|---|---|---|
| CD | Not described Receives: Other: CTE examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentages of surgery at one-year after diagnosis
percentages of surgery at one-year after diagnosis
Measured: 2017-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Jan 2022
- Primary completion20 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174208
- Sponsor's protocol ID
- 2021-ZSLYEC-341
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease
- ClinicalTrials.gov ID
- NCT05174208
- Acronym / sponsor ID
- 2021-ZSLYEC-341
- Conditions
- Crohn Disease, Prognostic Model, Radiomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 30 Dec 2021 (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.
Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. We aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD | – | Other: CTE examination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2017-2020 CD patients in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University.
Key inclusion criteria (1 listed)
- patients with a confirmed diagnosis of CD; a follow-up more than 1 year; without previous CD-associated intestinal surgeries; complete data of CTE.
Key exclusion criteria (1 listed)
- patients without a confirmed diagnosis of CD; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone CTE examination.
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 |
|---|---|---|
| CTE examinationeach patients should have undergone CTE examination | Other | CD |
Primary outcome
percentages of surgery at one-year after diagnosis
Time frame: 2017-2021
percentages of surgery at one-year after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Crohn Disease and Prognostic Model, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentages of surgery at one-year after diagnosis (time frame: 2017-2021). 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 29 Apr 2026.