Crohn Disease (CD)NCT07644390
Development of a Dynamic Prediction Model for Crohn's Disease-Related Intestinal Surgery Using Longitudinal Indices of Routine Blood Tests: A Single-Center Retrospective Cohort Study
An observational study of Crohn Disease (CD) and Dynamic Prediction Model, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
This single-center retrospective cohort study aims to develop and internally validate a dynamic prediction model that uses longitudinal data from routinely collected blood tests to continuously assess the risk of Crohn's disease (CD)-related intestinal surgery, and to construct a simplified tool for clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease (CD), Dynamic Prediction Model
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective cohort study included patients with a confirmed diagnosis of Crohn's disease (CD) at the Inflammatory Bowel Disease Center of the Sixth Affiliated Hospital of Sun Yat-sen University between January 1, 2010, and December 31, 2019. All patients had regular follow-up at this center for more than 5 years and had at least two routine blood tests available during follow-up. Data were retrospectively collected from electronic medical records, with the last follow-up date of December 31, 2026.
Who may be able to join
- Confirmed diagnosis of CD
- Regular follow-up at this center for more than 5 years
Who cannot join
- Incomplete clinical data
- Fewer than 2 blood tests during the follow-up period
About this study
Official title: Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort
This single-center retrospective cohort study aims to develop and internally validate a dynamic prediction model that uses longitudinal data from routinely collected blood tests to continuously assess the risk of Crohn's disease (CD)-related intestinal surgery, and to construct a simplified tool for clinical application. Patients with a confirmed diagnosis of CD and serial routine blood tests available during long-term follow-up will be included. Longitudinal trajectories of laboratory markers will be characterized, and their association with CD-related intestinal surgery will be evaluated. A full-variable dynamic prediction model will be built using dynamic random survival forest methodology, and a parsimonious model incorporating only the core laboratory markers will be developed via Bayesian joint model. The goal is to establish a practical, non-invasive, and dynamic risk assessment framework to support the transition from reactive to proactive long-term management of CD.
- Conditions
- Crohn Disease (CD), Dynamic Prediction Model
- Keywords
- Crohn Disease (CD), dynamic prediction model, multivariate functional principal component analysis, Random survival forests, Bayesian joint models
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort of Patients with Crohn's Disease | Patients with a confirmed diagnosis of Crohn's disease (CD) were identified from a single-center electronic medical record database. Eligible patients were those who had at least three routine blood test records available during long-term follow-up and for whom complete information on baseline characteristics and CD-related intestinal surgery events could be ascertained. Serial longitudinal data of routine blood parameters were retrospectively extracted. The cohort will be used to develop and internally validate a dynamic prediction model for CD-related intestinal surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's disease-related intestinal surgery
CD-related intestinal surgeries included intestinal resection, ostomy creation, and similar procedures. The onset of a CD-related intestinal surgery was defined as the time point when it was first detected on imaging during follow-up.
Measured: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2026, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jan 2010
- Primary completion31 Dec 2019
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn Disease (CD)Studies 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
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644390
- Sponsor's protocol ID
- 2025ZSLYEC-512
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data were collected retrospectively from routine clinical practice without specific informed consent for data sharing. Institutional ethics approval does not permit public deposition of patient-level data.
Publications
Ashton JJ, Satsangi J, Uhlig HH. Intestinal Inflammation and Extraintestinal Disease: Understanding Dynamic Risk. Gastroenterology. 2024 Jul;167(2):205-208. doi: 10.1053/j.gastro.2024.03.040. Epub 2024 Apr 10. No abstract available.
PubMed 38604541Zhou Q, Chen ZH, Peng S. Evaluating the application of dynamic prediction models in oncological prognostic studies with repeated measurement predictors. NPJ Precis Oncol. 2025 Nov 24;9(1):376. doi: 10.1038/s41698-025-01162-7.
PubMed 41286498
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort
- ClinicalTrials.gov ID
- NCT07644390
- Acronym / sponsor ID
- 2025ZSLYEC-512
- Conditions
- Crohn Disease (CD), Dynamic Prediction Model
- Keywords
- Crohn Disease (CD), dynamic prediction model, multivariate functional principal component analysis, Random survival forests, Bayesian joint models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 12 Jun 2026 (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.
This single-center retrospective cohort study aims to develop and internally validate a dynamic prediction model that uses longitudinal data from routinely collected blood tests to continuously assess the risk of Crohn's disease (CD)-related intestinal surgery, and to construct a simplified tool for clinical application. Patients with a confirmed diagnosis of CD and serial routine blood tests available during long-term follow-up will be included. Longitudinal trajectories of laboratory markers will be characterized, and their association with CD-related intestinal surgery will be evaluated. A full-variable dynamic prediction model will be built using dynamic random survival forest methodology, and a parsimonious model incorporating only the core laboratory markers will be developed via Bayesian joint model. The goal is to establish a practical, non-invasive, and dynamic risk assessment framework to support the transition from reactive to proactive long-term management of CD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort of Patients with Crohn's Disease | – | –Patients with a confirmed diagnosis of Crohn's disease (CD) were identified from a single-center electronic medical record database. Eligible patients were those who had at least three routine blood test records available during long-term follow-up and for whom complete information on baseline characteristics and CD-related intestinal surgery events could be ascertained. Serial longitudinal data of routine blood parameters were retrospectively extracted. The cohort will be used to develop and internally validate a dynamic prediction model for CD-related intestinal surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective cohort study included patients with a confirmed diagnosis of Crohn's disease (CD) at the Inflammatory Bowel Disease Center of the Sixth Affiliated Hospital of Sun Yat-sen University between January 1, 2010, and December 31, 2019. All patients had regular follow-up at this center for more than 5 years and had at least two routine blood tests available during follow-up. Data were retrospectively collected from electronic medical records, with the last follow-up date of December 31, 2026.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of CD
- Regular follow-up at this center for more than 5 years
Key exclusion criteria (2 listed)
- Incomplete clinical data
- Fewer than 2 blood tests during the follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Crohn's disease-related intestinal surgery
Time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2026, whichever occurred first.
CD-related intestinal surgeries included intestinal resection, ostomy creation, and similar procedures. The onset of a CD-related intestinal surgery was defined as the time point when it was first detected on imaging during follow-up.
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 12 Jun 2026.
- Results publication: PubMed 38604541Ashton JJ, Satsangi J, Uhlig HH. Intestinal Inflammation and Extraintestinal Disease: Understanding Dynamic Risk. Gastroenterology. 2024 Jul;167(2):205-208. doi: 10.1053/j.gastro.2024.03.040. Epub 2024 Apr 10. No abstract available.
- Results publication: PubMed 41286498Zhou Q, Chen ZH, Peng S. Evaluating the application of dynamic prediction models in oncological prognostic studies with repeated measurement predictors. NPJ Precis Oncol. 2025 Nov 24;9(1):376. doi: 10.1038/s41698-025-01162-7.
- Individual participant dataSharing planned: No. The individual participant data were collected retrospectively from routine clinical practice without specific informed consent for data sharing. Institutional ethics approval does not permit public deposition of patient-level data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD) and Dynamic Prediction Model, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 2 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Crohn's disease-related intestinal surgery (time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2026, whichever occurred first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07644390, which also lists 2 linked publications.
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 12 Jun 2026.