A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis

NCT06918093 | Not Yet Recruiting

• 1 other identifier: UC STUDY
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

• To evaluate the histological activity and the presence of specific histopathologic features at diagnosis in ulcerative colitis patients before and after receiving treatment using the three most widely- used histological scoring indices (Gobeos score , Robarts Histopathologic Index and Nancy Index )
• To compare the findings of the three histopathological indices with each other as a trial to select the best, reproducible, easily and consistently applied system that could be adopted in routine pathological evaluation. Moreover, an attempt to introduce a novel customized method of histopathological evaluation could be carried out.
• To correlate the clinical and endoscopic follow up data of patient on treatment with the histopathological evaluation. This will be done in order to evaluate the possible predictive effect of histopathological evaluation on the disease course and hence as a tool to drive possible modification of the therapeutic choices

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis, and their Correlation with Clinical Follow-up Data

  \-- To correlate the clinical and endoscopic follow up data of patient on treatment with the histopathological evaluation. This will be done in order to evaluate the possible predictive effect of histopathological evaluation on the disease course and hence as a tool to drive possible modification of the therapeutic choices

  4 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- The study will include 60 cases of patients diagnosed clinically and pathologically as ulcerative colitis and received therapeutic regimen at Department of Internal medicine ,Gastroenterology unit .- Biopsies of those patients will be reevaluated using the three histopathological indices; Gobeos score, Nancy Index and Robarts Histopathologic Index on hematoxylin and eosin stained slides

You may qualify if:

• Adult patients \>18 years diagnosed with ulcerative colitis based on standard clinical, endoscopic, and histological criteria

You may not qualify if:

• Patients lost to follow-up and those with insufficient data

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Marchal-Bressenot A, Salleron J, Boulagnon-Rombi C, Bastien C, Cahn V, Cadiot G, Diebold MD, Danese S, Reinisch W, Schreiber S, Travis S, Peyrin-Biroulet L. Development and validation of the Nancy histological index for UC. Gut. 2017 Jan;66(1):43-49. doi: 10.1136/gutjnl-2015-310187. Epub 2015 Oct 13.

  PMID: 26464414 BACKGROUND

• Jauregui-Amezaga A, Geerits A, Das Y, Lemmens B, Sagaert X, Bessissow T, Lobaton T, Ferrante M, Van Assche G, Bisschops R, Geboes K, De Hertogh G, Vermeire S. A Simplified Geboes Score for Ulcerative Colitis. J Crohns Colitis. 2017 Mar 1;11(3):305-313. doi: 10.1093/ecco-jcc/jjw154.

  PMID: 27571771 BACKGROUND

• Peyrin-Biroulet L, Arenson E, Rubin DT, Siegel CA, Lee S, Stephen Laroux F, Zhou W, Finney-Hayward T, Sanchez Gonzalez Y, Shields AL. A Comparative Evaluation of the Measurement Properties of Three Histological Indices of Mucosal Healing in Ulcerative Colitis: Geboes Score, Robarts Histopathology Index and Nancy Index. J Crohns Colitis. 2023 Nov 24;17(11):1733-1743. doi: 10.1093/ecco-jcc/jjad087.

  PMID: 37225135 BACKGROUND

• Le Berre C, Honap S, Peyrin-Biroulet L. Ulcerative colitis. Lancet. 2023 Aug 12;402(10401):571-584. doi: 10.1016/S0140-6736(23)00966-2.

  PMID: 37573077 BACKGROUND

• Magro F, Estevinho MM, Valois A. Managing Ulcerative Colitis and Crohn's Disease: Should the Target Be Endoscopy, Histology, or Both? J Can Assoc Gastroenterol. 2023 Sep 23;7(1):46-58. doi: 10.1093/jcag/gwad034. eCollection 2024 Feb.

  PMID: 38314174 BACKGROUND

• Pai RK, Khanna R, D'Haens GR, Sandborn WJ, Jeyarajah J, Feagan BG, Vande Casteele N, Jairath V. Definitions of response and remission for the Robarts Histopathology Index. Gut. 2019 Nov;68(11):2101-2102. doi: 10.1136/gutjnl-2018-317547. Epub 2018 Oct 26. No abstract available.

  PMID: 30366909 BACKGROUND

• Shehab M, Al Akram S, Hassan A, Alrashed F, Jairath V, Bessissow T. Histological Disease Activity as Predictor of Clinical Relapse, Hospitalization, and Surgery in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. Inflamm Bowel Dis. 2024 Apr 3;30(4):563-572. doi: 10.1093/ibd/izad119.

  PMID: 37541185 BACKGROUND

• Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.

  PMID: 33359090 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Thanaa Sotouhy, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Aya Mahmoud, demonestrator

CONTACT

+201159392242; AyaMahmoudMohamed@aun.edu.eg

Noha Abd El Rahim, Assistant Professor

CONTACT

+201007509759; nohah@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share