- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07608198
Validation of the Reliability and Validity of the New Endoscopic Scoring System for Ulcerative Colitis (CAT-DESIRE Score) and Verification of Its Clinical Practicability
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, Čína, 100700
- The Seventh Medical Center of PLA General Hospital
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Hubei
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Wuhan, Hubei, Čína, 430022
- Wuhan Union Hospital Of China
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Shaanxi
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Xi'an, Shaanxi, Čína, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'an, Shaanxi, Čína, 710032
- Xijing Hospital of Digestive Disease
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200127
- RenJi Hospital
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Shanghai, Shanghai Municipality, Čína, 200025
- Ruijin Hospital
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Sichuan
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Chengdu, Sichuan, Čína, 610041
- West China Hospital
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Xinjiang
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Ürümqi, Xinjiang, Čína, 830000
- The First Affiliated Hospital of Xinjiang Medical University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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CAT-DESIRE Assessment Group
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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The two clear colonoscopy images before and after the treatment
Časové okno: Three months after receiving any standard UC treatment , including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs, etc.
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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).
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Three months after receiving any standard UC treatment , including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs, etc.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Blood white blood cell count test
Časové okno: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Blood white blood cell count test results
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Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Hemoglobin
Časové okno: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Hemoglobin test results
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Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Platelet count test
Časové okno: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Platelet count test results
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Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Serum albumin test
Časové okno: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Serum albumin test results
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Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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ESR
Časové okno: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Erythrocyte sedimentation rates
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Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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CRP
Časové okno: Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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C-reactive protein test results
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Three months after receiving any standard UC treatment, including mesalazine, steroids, immunosuppressants, biologics and small molecule drugs.
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lemann M, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Bernhardt CA, Mary JY, Sandborn WJ. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut. 2012 Apr;61(4):535-42. doi: 10.1136/gutjnl-2011-300486. Epub 2011 Oct 13.
- 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.
- Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- XijingHDD-UC-CAT-DESIRE
- 82370588 (Jiné číslo grantu/financování: The National Natural Science Foundation of China General Program)
- 82570614 (Jiné číslo grantu/financování: The National Natural Science Foundation of China General Program)
- XJZT25CX41 (Jiné číslo grantu/financování: The innovative medical research boosting project)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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