Validation of the Reliability and Validity of the New Endoscopic Scoring System for Ulcerative Colitis (CAT-DESIRE Score) and Verification of Its Clinical Practicability

May 24, 2026 updated by: Jie Liang, Xijing Hospital of Digestive Diseases

Ulcerative Colitis (UC) is a chronic, non-specific intestinal inflammatory disease of unknown cause, featuring abdominal pain, diarrhea, and bloody stools. Endoscopy shows diffuse, continuous lesions with erosion and shallow ulcers, worst in the rectum and diminishing proximally. Current treatments (aminosalicylates, corticosteroids, immunosuppressants, biologics, small molecule drugs) are not curative. Endoscopic mucosal healing is a key treatment goal, improving steroid-free remission, reducing colectomy rates, recurrence, hospitalization, and colorectal cancer risk.

Common endoscopic scoring systems: Baron score (poor consistency), Mayo Endoscopic Score (MES, simple but lacks prognostic info), and Ulcerative Colitis Endoscopic Severity Index (UCEIS, more detailed and consistent but cumbersome). Disease extent is important for severity, as proximal extension increases relapse, treatment escalation, and cancer risk. However, MES and UCEIS assess only the worst segment, underestimating total disease burden.

Other scores (UCCIS, MMES, DUBLIN) attempt to incorporate lesion extent but have limitations (small samples, lack of validation, unclear severity cutoffs). Data on short-/medium-term endoscopic changes and long-term outcomes are scarce.

We therefore propose a new endoscopic scoring system, the CAT-DESIRE score, aiming to evaluate its reliability, validity, and predictive role in medium-/long-term prognosis and treatment response, providing a simple, accurate tool for assessing disease burden and guiding clinical decisions.

Study Overview

Status

Completed

Conditions

Detailed Description

Ulcerative Colitis (UC) is a chronic, non-specific inflammatory disease of the intestine with unknown causes and mechanisms. Its main clinical manifestations include abdominal pain, diarrhea, and bloody stools. The typical endoscopic appearance of UC is diffuse and continuous lesions, accompanied by erosion and shallow ulcers. The lesions are most severe in the rectum and gradually become less severe towards the proximal part. Currently, the main therapeutic drugs for UC include aminosalicylic acid preparations, corticosteroids, immunosuppressants, biologics, and small molecule drugs, but there is no cure. The choice of treatment plan is based on a comprehensive assessment of the disease. Endoscopic examination can objectively determine the lesion range and assess the disease activity, which is of great significance for monitoring treatment response and providing individualized optimal treatment plans. Endoscopic mucosal healing has become an important goal in the treatment of UC, and it has been proven to achieve better long-term efficacy, including increasing the rate of steroid-free remission, reducing the need for colectomy, and lowering the risks of recurrence, hospitalization, and colorectal cancer.

There are several endoscopic scoring systems currently applied in clinical and research assessment of UC. Different endoscopic scoring tools have different advantages and limitations. The initial endoscopic classification of UC was the Baron score, which, due to not measuring the consistency indicators among researchers, had a 40% disagreement in classifying normal, mild, moderate, or severe activity, and there was little supporting data. The Mayo endoscopic score (MES) and the Ulcerative Colitis Endoscopic Severity Index (UCEIS) are currently the two main endoscopic scoring systems for evaluating mucosal inflammation symptoms and disease activity. MES is easy to use but lacks information on disease prognosis. UCEIS distinguishes mucosal inflammation and disease activity more detailedly through a greater number of layers (0-8) than MES (0-3), and shows higher internal and inter-rater consistency, but is more computationally cumbersome.

The disease range is potentially important in evaluating the severity of UC. The IBSEN study showed that disease expansion is an important independent factor for colectomy in UC patients. Qiu and his colleagues further proved that proximal disease expansion would increase the risk of recurrence and treatment intensification. Additionally, Ekbom et al. and Lutgens MW et al. also reported a close relationship between colorectal cancer and disease expansion. Therefore, quantifying the inflammatory load is crucial for individualized treatment of UC patients. However, the MES and UCEIS scoring systems only consider the most severely affected intestinal segment, thereby underestimating the actual disease range and burden. For example, for a patient with total colitis, multiple large ulcers, and a baseline Mayo endoscopic score of 3, if there is improvement after treatment but still has a single ulcer in the sigmoid colon, the Mayo endoscopic score remains 3 and belongs to endoscopic non-response.

The Ulcerative Colitis Colon Severity Index (UCCIS) takes into account four different variables (granularity, vascular pattern, ulcers, and bleeding-fragility) for all colon segments and shows correlation with clinical indicators and laboratory parameters of disease activity. However, due to the small sample size, its feasibility and simplicity need to be proven in clinical practice. The Modified Mayo Endoscopic Score (MMES) is based on the Mayo endoscopic score and combines the degree of mucosal inflammation and lesion distribution in different intestinal segments, better reflecting endoscopic response and improvement numerically. However, this score does not have a clear boundary for disease severity and lacks inter-rater and inter-observer consistency validation, which may change the proportion of patients defined as remission and affect treatment or regulatory decisions. The DUBLIN scoring method for the degree of luminal inflammation burden in ulcerative colitis, published by Rowan et al. in 2019, is the product of MES (0-3) and the disease lesion range (E1-E3). This scoring method shows a good correlation with MES, UCEIS, fecal calcium protein, and other inflammatory markers, as well as histological activity. However, due to the single-center study and the small sample size, the inter-observer and intra-observer consistency has not yet been verified.

At present, there are few data on how endoscopic changes in the short and medium term affect long-term clinical outcomes. By combining the advantages and limitations of different UC endoscopic scoring systems published previously, we propose a new endoscopic scoring system - the CAT-DESIRE score. We hope to evaluate the reliability and validity of the CAT-DESIRE score, verify its predictive role in medium- and long-term prognosis, therapeutic efficacy and adjustment, and provide a reliable and simple tool for comprehensive and accurate assessment of the disease burden and treatment effect of UC patients, in order to better guide clinical treatment decisions.

Study Type

Observational

Enrollment (Actual)

235

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

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100700
        • The Seventh Medical Center of PLA General Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital Of China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital of Digestive Disease
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • RenJi Hospital
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • The First Affiliated Hospital of Xinjiang Medical University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A total of 235 UC patients were recruited from 9 specialized IBD diagnosis and therapy centers across China, with all patients undergoing paired endoscopic evaluations. Nine specialized IBD diagnosis and therapy centers are the Air Force Military Medical University First Affiliated Hospital, the Beijing Peking Union Medical College Hospital, the Xi'an Jiaotong University Affiliated Second Hospital, the Shanghai Ruijin Hospital, the Xinjiang Urumqi Affiliated First Hospital, the Sichuan Huaxi Hospital, the Wuhan Xiehe Hospital, the Shanghai Jiao Tong Renji Hospital, and the Seventh Medical Center of PLA General Hospital.

Description

Inclusion Criteria:

  • 1. Adult patients (aged 18 - 75 years);
  • 2. Diagnosed with ulcerative colitis for at least 3 months;
  • 3. Have had endoscopic examination results for at least 2 times, with clear endoscopic images (including endoscopic pictures of the terminal ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum at least one picture for each of these 7 areas);
  • 4. Complete clinical data.

Exclusion Criteria:

  • 1. Crohn's disease, intestinal Behcet's disease, intestinal tuberculosis, toxic megacolon and unclassified inflammatory bowel disease.
  • 2. The length of the colon lesion could not be evaluated.

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

Cohorts and Interventions

Group / Cohort
CAT-DESIRE Assessment Group
  1. Multiple centers recruit participants, and the collection of the following participant information, two clear colonoscopy images, age, gender, BMI, lesion range, duration of the disease, extraintestinal manifestations, history of related surgeries for ulcerative colitis, routine blood tests, serum albumin, erythrocyte sedimentation rate, C-reactive protein, drug treatment and adjustment status;
  2. Conducting Mayo endoscopy scoring, UCEIS scoring, MMES scoring, and CAT-DESIRE scoring for the two colonoscopy images of the participants;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The two clear colonoscopy images before and after the treatment
Time Frame: Three months after receiving any standard UC treatment , including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs, etc.
Two clear colonoscopy images before and after treatment must include at least one photo of each of the seven parts: the terminal ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum. A single researcher reviews the quality of the colonoscopy images and selects records with satisfactory quality (clear images and adequate bowel preparation).
Three months after receiving any standard UC treatment , including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs, etc.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood white blood cell count test
Time Frame: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Blood white blood cell count test results
Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Hemoglobin
Time Frame: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Hemoglobin test results
Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Platelet count test
Time Frame: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Platelet count test results
Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Serum albumin test
Time Frame: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Serum albumin test results
Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
ESR
Time Frame: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
Erythrocyte sedimentation rates
Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
CRP
Time Frame: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
C-reactive protein test results
Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XijingHDD-UC-CAT-DESIRE
  • 82370588 (Other Grant/Funding Number: The National Natural Science Foundation of China General Program)
  • 82570614 (Other Grant/Funding Number: The National Natural Science Foundation of China General Program)
  • XJZT25CX41 (Other Grant/Funding Number: The innovative medical research boosting project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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