Ulcerative Colitis (Disorder)NCT07784114
Incremental Value of Traditional Chinese Medicine Features in Two-Stage Pre-Endoscopic Prediction
An observational study of Ulcerative Colitis (Disorder) and Crohn Disease (CD), run by Beijing University of Chinese Medicine.
Trial summary
This observational study evaluates whether adding Traditional Chinese Medicine (TCM)-related clinical features improves the performance of machine-learning models that estimate disease risk before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis (Disorder), Crohn Disease (CD), Inflammatory Bowel Diseases
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adults from multiple participating centers in China who underwent clinical evaluation and colonoscopy-related diagnostic work-up for suspected functional bowel disorders or colorectal inflammatory / neoplastic disease. A development cohort is used to train two-stage machine-learning prediction models under Western-only and TCM-integrated strategies. Independent external-validation cohorts from other centers are used to assess generalizability. No study treatment is assigned; analyses use existing clinical data collected under institutional approvals.
Who may be able to join
- Adults aged 18 years or older Patients evaluated in participating centers with clinical records suitable for pre-endoscopic risk assessment related to colorectal inflammatory or functional bowel conditions Underwent colonoscopy (or had a colonoscopy-confirmed final diagnosis) allowing assignment to the study diagnostic labels used in the two-stage framework Stage 1-eligible diagnoses classifiable as either a functional-predominant pathway (e.g., irritable bowel syndrome / related functional presentations as defined in the protocol) or an inflammatory-neoplastic pathway (ulcerative colitis, Crohn disease, indeterminate colitis, or colorectal neoplasia as defined in the protocol) For Stage 2 analyses: patients within the inflammatory-neoplastic pathway classifiable as ulcerative colitis versus other inflammatory or neoplastic conditions (Crohn disease, indeterminate colitis, or colorectal neoplasia) Availability of required Western clinical and laboratory predictors for model development or validation For TCM-integrated analyses: availability of protocol-defined structured Traditional Chinese Medicine (TCM) features Ability to assign the record to the development cohort or an independent external-validation cohort according to the protocol center rules
Who cannot join
- Age younger than 18 years Missing or unverifiable final diagnostic label required for Stage 1 and/or Stage 2 Missing key predictors required by the Western-only and/or TCM-integrated modeling pipelines (per protocol variable lists) Diagnosis outside the predefined Stage 1 / Stage 2 label sets and not mappable under protocol rules Duplicate or overlapping records for the same patient encounter after de-duplication Records excluded by pre-specified data-quality or center-specific protocol rules (e.g., incomplete critical clinical documentation)
About this study
Official title: Incremental Value of a Traditional Chinese Medicine-Integrated Versus Western-Only Strategy for Two-Stage Pre-Endoscopic Prediction of Colorectal Inflammatory Conditions: A Multicenter Diagnostic Model Development and External Validation Study
This observational study evaluates whether adding Traditional Chinese Medicine (TCM)-related clinical features improves the performance of machine-learning models that estimate disease risk before colonoscopy.
We compare two modeling strategies that use the same sequential (two-stage) framework:
Read more
Western-only models, based on demographic, clinical, and laboratory information commonly used in Western medicine.
TCM-integrated models, which use the same types of Western information plus structured TCM features.
Stage 1 aims to distinguish people more likely to have functional bowel problems from those more likely to have inflammatory or neoplastic colorectal disease.
Stage 2 focuses on people in the higher-risk pathway and aims to distinguish ulcerative colitis from other inflammatory or neoplastic conditions.
Models are developed in one dataset and tested in independent external data from other centers. We assess discrimination (including AUC), clinical usefulness with decision-curve analysis, and which TCM features contribute most in the integrated models.
This study does not assign treatments. It analyzes existing clinical information to support future pre-endoscopic triage research. Results will not replace colonoscopy or clinician judgment.
Read the detailed description
Background and rationale. Colonoscopy remains essential for diagnosing ulcerative colitis (UC) and related colorectal inflammatory or neoplastic conditions, but pre-endoscopic risk stratification may help prioritize evaluation. Machine-learning models based on Western clinical and laboratory variables have been developed for sequential triage. Whether structured TCM features provide incremental value beyond a Western-only strategy is less clear and is the focus of this record (TCM-PREDICT).
Study design. Multicenter, observational, retrospective diagnostic modeling study with model development and external validation. No investigational drug, device, or care pathway is assigned by the protocol.
Modeling framework.
Two parallel strategies share the same two-stage prediction structure and are compared using matched algorithm indices where applicable:
Western-only strategy: candidate predictors limited to Western demographic, clinical, and laboratory variables.
TCM-integrated strategy: Western variables plus rule-structured TCM features collected in routine integrative practice.
Stage 1 addresses separation of a lower-risk / functional-predominant pathway from an inflammatory-neoplastic pathway.
Stage 2 addresses separation of UC from other inflammatory or neoplastic conditions within the higher-risk pathway.
Analysis overview (high level). Primary emphasis is strategy-level incremental value (TCM-integrated versus Western-only), summarized across internal validation, external validation, and decision-curve analysis. Feature-level interpretation for the TCM-integrated models (e.g., SHAP-based importance of TCM variables) is secondary and explanatory. Subgroup summaries (e.g., by center or age band) may be reported descriptively.
Data and participants. De-identified clinical records from participating centers are used under institutional approvals. Eligibility, sample size, outcomes, and calendar dates are specified in the corresponding registry fields and should not be repeated here at length.
Patient care implications. Findings are intended for research on pre-endoscopic prediction and triage. Models are not a substitute for endoscopy or clinical decision-making.
- Conditions
- Ulcerative Colitis (Disorder), Crohn Disease (CD), Inflammatory Bowel Diseases, Colorectal Neoplasms
- Keywords
- Traditional Chinese Medicine, TCM-integrated model, Western medicine model, Machine learning, Decision curve analysis
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in External-Validation AUC (ΔAUC) Between TCM-Integrated and Western-Only Two-Stage Pre-Endoscopic Prediction Models
The primary outcome is the difference in area under the receiver operating characteristic curve (ΔAUC = AUC_TCM-integrated - AUC_Western-only) for matched machine-learning algorithms assessed in independent external validation. ΔAUC is reported for the two sequential prediction stages: Stage 1 (functional-predominant versus inflammatory-neoplastic pathway) and Stage 2 (ulcerative colitis versus other inflammatory or neoplastic conditions). Higher ΔAUC indicates greater incremental discriminative value of the TCM-integrated strategy.
Measured: Baseline (index visit; all pre-endoscopic assessments within 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Jan 2015
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Liu, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784114
- Sponsor's protocol ID
- 82374298
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing is currently undecided. Release of patient-level data may be limited by hospital agreements, ethics approvals, and confidentiality obligations; any future sharing would require institutional approval and appropriate de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Value of a Traditional Chinese Medicine-Integrated Versus Western-Only Strategy for Two-Stage Pre-Endoscopic Prediction of Colorectal Inflammatory Conditions: A Multicenter Diagnostic Model Development and External Validation Study
- ClinicalTrials.gov ID
- NCT07784114
- Acronym / sponsor ID
- 82374298
- Conditions
- Ulcerative Colitis (Disorder), Crohn Disease (CD), Inflammatory Bowel Diseases, Colorectal Neoplasms
- Keywords
- Traditional Chinese Medicine, TCM-integrated model, Western medicine model, Machine learning, Decision curve analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 25 Aug 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 observational study evaluates whether adding Traditional Chinese Medicine (TCM)-related clinical features improves the performance of machine-learning models that estimate disease risk before colonoscopy.
We compare two modeling strategies that use the same sequential (two-stage) framework:
Western-only models, based on demographic, clinical, and laboratory information commonly used in Western medicine.
TCM-integrated models, which use the same types of Western information plus structured TCM features.
Stage 1 aims to distinguish people more likely to have functional bowel problems from those more likely to have inflammatory or neoplastic colorectal disease.
Stage 2 focuses on people in the higher-risk pathway and aims to distinguish ulcerative colitis from other inflammatory or neoplastic conditions.
Models are developed in one dataset and tested in independent external data from other centers. We assess discrimination (including AUC), clinical usefulness with decision-curve analysis, and which TCM features contribute most in the integrated models.
This study does not assign treatments. It analyzes existing clinical information to support future pre-endoscopic triage research. Results will not replace colonoscopy or clinician judgment.
Detailed description
Background and rationale. Colonoscopy remains essential for diagnosing ulcerative colitis (UC) and related colorectal inflammatory or neoplastic conditions, but pre-endoscopic risk stratification may help prioritize evaluation. Machine-learning models based on Western clinical and laboratory variables have been developed for sequential triage. Whether structured TCM features provide incremental value beyond a Western-only strategy is less clear and is the focus of this record (TCM-PREDICT).
Study design. Multicenter, observational, retrospective diagnostic modeling study with model development and external validation. No investigational drug, device, or care pathway is assigned by the protocol.
Modeling framework.
Two parallel strategies share the same two-stage prediction structure and are compared using matched algorithm indices where applicable:
Western-only strategy: candidate predictors limited to Western demographic, clinical, and laboratory variables.
TCM-integrated strategy: Western variables plus rule-structured TCM features collected in routine integrative practice.
Stage 1 addresses separation of a lower-risk / functional-predominant pathway from an inflammatory-neoplastic pathway.
Stage 2 addresses separation of UC from other inflammatory or neoplastic conditions within the higher-risk pathway.
Analysis overview (high level). Primary emphasis is strategy-level incremental value (TCM-integrated versus Western-only), summarized across internal validation, external validation, and decision-curve analysis. Feature-level interpretation for the TCM-integrated models (e.g., SHAP-based importance of TCM variables) is secondary and explanatory. Subgroup summaries (e.g., by center or age band) may be reported descriptively.
Data and participants. De-identified clinical records from participating centers are used under institutional approvals. Eligibility, sample size, outcomes, and calendar dates are specified in the corresponding registry fields and should not be repeated here at length.
Patient care implications. Findings are intended for research on pre-endoscopic prediction and triage. Models are not a substitute for endoscopy or clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adults from multiple participating centers in China who underwent clinical evaluation and colonoscopy-related diagnostic work-up for suspected functional bowel disorders or colorectal inflammatory / neoplastic disease. A development cohort is used to train two-stage machine-learning prediction models under Western-only and TCM-integrated strategies. Independent external-validation cohorts from other centers are used to assess generalizability. No study treatment is assigned; analyses use existing clinical data collected under institutional approvals.
Key inclusion criteria (1 listed)
- Adults aged 18 years or older Patients evaluated in participating centers with clinical records suitable for pre-endoscopic risk assessment related to colorectal inflammatory or functional bowel conditions Underwent colonoscopy (or had a colonoscopy-confirmed final diagnosis) allowing assignment to the study diagnostic labels used in the two-stage framework Stage 1-eligible diagnoses classifiable as either a functional-predominant pathway (e.g., irritable bowel syndrome / related functional presentations as defined in the protocol) or an inflammatory-neoplastic pathway (ulcerative colitis, Crohn disease, indeterminate colitis, or colorectal neoplasia as defined in the protocol) For Stage 2 analyses: patients within the inflammatory-neoplastic pathway classifiable as ulcerative colitis versus other inflammatory or neoplastic conditions (Crohn disease, indeterminate colitis, or colorectal neoplasia) Availability of required Western clinical and laboratory predictors for model development or validation For TCM-integrated analyses: availability of protocol-defined structured Traditional Chinese Medicine (TCM) features Ability to assign the record to the development cohort or an independent external-validation cohort according to the protocol center rules
Key exclusion criteria (1 listed)
- Age younger than 18 years Missing or unverifiable final diagnostic label required for Stage 1 and/or Stage 2 Missing key predictors required by the Western-only and/or TCM-integrated modeling pipelines (per protocol variable lists) Diagnosis outside the predefined Stage 1 / Stage 2 label sets and not mappable under protocol rules Duplicate or overlapping records for the same patient encounter after de-duplication Records excluded by pre-specified data-quality or center-specific protocol rules (e.g., incomplete critical clinical documentation)
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
Difference in External-Validation AUC (ΔAUC) Between TCM-Integrated and Western-Only Two-Stage Pre-Endoscopic Prediction Models
Time frame: Baseline (index visit; all pre-endoscopic assessments within 1 day)
The primary outcome is the difference in area under the receiver operating characteristic curve (ΔAUC = AUC_TCM-integrated - AUC_Western-only) for matched machine-learning algorithms assessed in independent external validation. ΔAUC is reported for the two sequential prediction stages: Stage 1 (functional-predominant versus inflammatory-neoplastic pathway) and Stage 2 (ulcerative colitis versus other inflammatory or neoplastic conditions). Higher ΔAUC indicates greater incremental discriminative value of the TCM-integrated strategy.
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing is currently undecided. Release of patient-level data may be limited by hospital agreements, ethics approvals, and confidentiality obligations; any future sharing would require institutional approval and appropriate de-identification.
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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 Ulcerative Colitis (Disorder) and Crohn Disease (CD), run by Beijing University of Chinese Medicine.
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 25 Aug 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?
Difference in External-Validation AUC (ΔAUC) Between TCM-Integrated and Western-Only Two-Stage Pre-Endoscopic Prediction Models (time frame: Baseline (index visit; all pre-endoscopic assessments within 1 day)). 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 25 Aug 2026.