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

NCT07608198 | Completed

• 4 other identifiers: XijingHDD-UC-CAT-DESIRE8237058882570614XJZT25CX41
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• The two clear colonoscopy images before and after the treatment

  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 Outcomes (6)

• Blood white blood cell count test

  Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.

• Hemoglobin

  Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.

• Platelet count test

  Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.

• Serum albumin test

  Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.

• ESR

  Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.

Study Arms (1)

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;

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Adult patients (aged 18 - 75 years);
• \. Diagnosed with ulcerative colitis for at least 3 months;
• \. 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);
• \. Complete clinical data.

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (9)

The Seventh Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100700, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Wuhan Union Hospital of China

Wuhan, Hubei, 430022, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

Location

Related Publications (10)

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  PMID: 21997563 BACKGROUND

• BARON JH, CONNELL AM, LENNARD-JONES JE. VARIATION BETWEEN OBSERVERS IN DESCRIBING MUCOSAL APPEARANCES IN PROCTOCOLITIS. Br Med J. 1964 Jan 11;1(5375):89-92. doi: 10.1136/bmj.1.5375.89. No abstract available.

  PMID: 14075156 BACKGROUND

• Harbord M, Eliakim R, Bettenworth D, Karmiris K, Katsanos K, Kopylov U, Kucharzik T, Molnar T, Raine T, Sebastian S, de Sousa HT, Dignass A, Carbonnel F; European Crohn's and Colitis Organisation [ECCO]. Corrigendum: Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Dec 4;11(12):1512. doi: 10.1093/ecco-jcc/jjx105. No abstract available.

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• Lichtenstein GR, Rutgeerts P. Importance of mucosal healing in ulcerative colitis. Inflamm Bowel Dis. 2010 Feb;16(2):338-46. doi: 10.1002/ibd.20997.

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• Colombel JF, Rutgeerts P, Reinisch W, Esser D, Wang Y, Lang Y, Marano CW, Strauss R, Oddens BJ, Feagan BG, Hanauer SB, Lichtenstein GR, Present D, Sands BE, Sandborn WJ. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology. 2011 Oct;141(4):1194-201. doi: 10.1053/j.gastro.2011.06.054. Epub 2011 Jun 30.

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• Ardizzone S, Cassinotti A, Duca P, Mazzali C, Penati C, Manes G, Marmo R, Massari A, Molteni P, Maconi G, Porro GB. Mucosal healing predicts late outcomes after the first course of corticosteroids for newly diagnosed ulcerative colitis. Clin Gastroenterol Hepatol. 2011 Jun;9(6):483-489.e3. doi: 10.1016/j.cgh.2010.12.028. Epub 2010 Dec 31.

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• Le Berre C, Ricciuto A, Peyrin-Biroulet L, Turner D. Evolving Short- and Long-Term Goals of Management of Inflammatory Bowel Diseases: Getting It Right, Making It Last. Gastroenterology. 2022 Apr;162(5):1424-1438. doi: 10.1053/j.gastro.2021.09.076. Epub 2022 Jan 4.

  PMID: 34995529 BACKGROUND

• D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.

  PMID: 17258735 BACKGROUND

• Raine T, Bonovas S, Burisch J, Kucharzik T, Adamina M, Annese V, Bachmann O, Bettenworth D, Chaparro M, Czuber-Dochan W, Eder P, Ellul P, Fidalgo C, Fiorino G, Gionchetti P, Gisbert JP, Gordon H, Hedin C, Holubar S, Iacucci M, Karmiris K, Katsanos K, Kopylov U, Lakatos PL, Lytras T, Lyutakov I, Noor N, Pellino G, Piovani D, Savarino E, Selvaggi F, Verstockt B, Spinelli A, Panis Y, Doherty G. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2022 Jan 28;16(1):2-17. doi: 10.1093/ecco-jcc/jjab178. No abstract available.

  PMID: 34635919 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 27, 2026
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)