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

24 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

235

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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;

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The two clear colonoscopy images before and after the treatment
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Blood white blood cell count test
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de fevereiro de 2024

Conclusão Primária (Real)

1 de dezembro de 2025

Conclusão do estudo (Real)

1 de maio de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de maio de 2026

Primeira postagem (Real)

27 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • XijingHDD-UC-CAT-DESIRE
  • 82370588 (Número de outro subsídio/financiamento: The National Natural Science Foundation of China General Program)
  • 82570614 (Número de outro subsídio/financiamento: The National Natural Science Foundation of China General Program)
  • XJZT25CX41 (Número de outro subsídio/financiamento: The innovative medical research boosting project)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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