Ulcerative ColitisNCT06918093
A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Adult patients >18 years diagnosed with ulcerative colitis based on standard clinical, endoscopic, and histological criteria
Who cannot join
- Patients lost to follow-up and those with insufficient data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis, and Their Correlation With Clinical Follow-up Data
- 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
Read the detailed description
Ulcerative colitis (UC) is a chronic inflammatory disease of idiopathic origin affecting the rectum and colon. Patients classically manifest with rectal bleeding, diarrhea, tenesmus, urgency, abdominal pain, weight loss, fever, and malaise. Pathologically, it is defined by a continuous mucosal inflammation of the rectum and a variable extent of the colon, without granulomas on mucosal biopsies. The course of UC is characterized by periods of remission and relapsing. In patients with extensive or severe inflammation, acute complications such as severe bleeding and toxic megacolon, which can lead to perforation, may occur. Patients newly diagnosed with UC have a 5-year risk of colectomy of 10-35%, and ultimately, persistent and extensive inflammatory activity increases the long-term risk of dysplasia and colorectal cancer.
While treatment of patients with UC is primarily aiming to achieve clinical remission (CR) and endoscopic remission (ER), there is now interest in targeting histological healing (HH) in addition to CR, as symptoms may not reliably correlate with histological activity. Moreover, ER is not always an accurate indicator of histological healing. Furthermore, histological changes tend to lag behind CR after treatment. Accordingly, histological remission may be considered as an independent predictor of clinical relapse better than endoscopic appearances.
The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) II committee introduced a treat-to-target approach and proposed that the therapeutic target in UC should include clinical and patient-reported outcome remission, alongside endoscopic remission, with Mayo endoscopic subscore of 0. Histologic remission is not a formal target of medical therapy, but it is considered an "adjunct to endoscopic remission to represent a deeper level of healing.
However, Various studies have elucidated that histologic remission serves as a distinct treatment objective from endoscopic remission, offering a superior prediction of clinical remission. In few studies, histological remission seems to correlate with long-term clinical remission, better clinical outcomes, and a lower risk of intestinal dysplasia, even though significant data are still lacking.
Currently, about 30 histologic scoring systems in UC have been described and used for quantitative assessment, but 3 have recently undergone scientific validation namely the Gobeos score (GS), Nancy Index (NI) and Robarts Histopathologic Index (RHI). For histologic measurements of disease activity to affect clinical decision making, pathologists should agree upon which standardized features to report and the definitions of these parameters.
GS evaluates all aspects of mucosal injury seen in UC including crypt architecture, lamina propria chronic inflammation, lamina propria eosinophils, lamina propria neutrophils, intraepithelial neutrophils, crypt destruction, and surface epithelial injury.
The RHI was developed based on several reproducible features included in the final index (lamina propria chronic inflammation, lamina propria neutrophils, neutrophils in the epithelium, and surface epithelial injury). Although the RHI was specifically designed to be responsive and reproducible, it requires assessment of 4 features to arrive at a calculated score, which may reduce its clinical usefulness.
The NI is a stepwise 5-item index that evaluates lamina propria chronic inflammation (defined as lymphocytes, plasma cells, and eosinophils), neutrophilic inflammation, and ulcers.
It is unclear which of these histologic scoring indices is most useful in clinical practice. In this context, it is important that pathologists to include important, reproducible histologic features in a pathology report that could be correlated better with clinical management. In addition, the development and validation of novel histologic scoring systems, better correlate with CR and ER, should be tried out.
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mahmoud Mohamed, Assiut University
- Investigators
- Thanaa Sotouhy, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918093
- Sponsor's protocol ID
- UC STUDY
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26464414Jauregui-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.
PubMed 27571771Peyrin-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.
PubMed 37225135Le 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.
PubMed 37573077Magro 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.
PubMed 38314174Pai 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.
PubMed 30366909Shehab 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.
PubMed 37541185Turner 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.
PubMed 33359090
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis, and Their Correlation With Clinical Follow-up Data
- ClinicalTrials.gov ID
- NCT06918093
- Acronym / sponsor ID
- UC STUDY
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory disease of idiopathic origin affecting the rectum and colon. Patients classically manifest with rectal bleeding, diarrhea, tenesmus, urgency, abdominal pain, weight loss, fever, and malaise. Pathologically, it is defined by a continuous mucosal inflammation of the rectum and a variable extent of the colon, without granulomas on mucosal biopsies. The course of UC is characterized by periods of remission and relapsing. In patients with extensive or severe inflammation, acute complications such as severe bleeding and toxic megacolon, which can lead to perforation, may occur. Patients newly diagnosed with UC have a 5-year risk of colectomy of 10-35%, and ultimately, persistent and extensive inflammatory activity increases the long-term risk of dysplasia and colorectal cancer.
While treatment of patients with UC is primarily aiming to achieve clinical remission (CR) and endoscopic remission (ER), there is now interest in targeting histological healing (HH) in addition to CR, as symptoms may not reliably correlate with histological activity. Moreover, ER is not always an accurate indicator of histological healing. Furthermore, histological changes tend to lag behind CR after treatment. Accordingly, histological remission may be considered as an independent predictor of clinical relapse better than endoscopic appearances.
The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) II committee introduced a treat-to-target approach and proposed that the therapeutic target in UC should include clinical and patient-reported outcome remission, alongside endoscopic remission, with Mayo endoscopic subscore of 0. Histologic remission is not a formal target of medical therapy, but it is considered an "adjunct to endoscopic remission to represent a deeper level of healing.
However, Various studies have elucidated that histologic remission serves as a distinct treatment objective from endoscopic remission, offering a superior prediction of clinical remission. In few studies, histological remission seems to correlate with long-term clinical remission, better clinical outcomes, and a lower risk of intestinal dysplasia, even though significant data are still lacking.
Currently, about 30 histologic scoring systems in UC have been described and used for quantitative assessment, but 3 have recently undergone scientific validation namely the Gobeos score (GS), Nancy Index (NI) and Robarts Histopathologic Index (RHI). For histologic measurements of disease activity to affect clinical decision making, pathologists should agree upon which standardized features to report and the definitions of these parameters.
GS evaluates all aspects of mucosal injury seen in UC including crypt architecture, lamina propria chronic inflammation, lamina propria eosinophils, lamina propria neutrophils, intraepithelial neutrophils, crypt destruction, and surface epithelial injury.
The RHI was developed based on several reproducible features included in the final index (lamina propria chronic inflammation, lamina propria neutrophils, neutrophils in the epithelium, and surface epithelial injury). Although the RHI was specifically designed to be responsive and reproducible, it requires assessment of 4 features to arrive at a calculated score, which may reduce its clinical usefulness.
The NI is a stepwise 5-item index that evaluates lamina propria chronic inflammation (defined as lymphocytes, plasma cells, and eosinophils), neutrophilic inflammation, and ulcers.
It is unclear which of these histologic scoring indices is most useful in clinical practice. In this context, it is important that pathologists to include important, reproducible histologic features in a pathology report that could be correlated better with clinical management. In addition, the development and validation of novel histologic scoring systems, better correlate with CR and ER, should be tried out.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Adult patients >18 years diagnosed with ulcerative colitis based on standard clinical, endoscopic, and histological criteria
Key exclusion criteria (1 listed)
- Patients lost to follow-up and those with insufficient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis, and their Correlation with Clinical Follow-up Data
Time frame: 4 months
-- 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 26464414Marchal-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.
- Background: PubMed 27571771Jauregui-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.
- Background: PubMed 37225135Peyrin-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.
- Background: PubMed 37573077Le 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.
- Background: PubMed 38314174Magro 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.
- Background: PubMed 30366909Pai 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.
- Background: PubMed 37541185Shehab 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.
- Background: PubMed 33359090Turner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thanaa Sotouhy, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Mahmoud, demonestrator (+201159392242, AyaMahmoudMohamed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Comparative Evaluation of Different Histopathological Indices of Mucosal Healing in Ulcerative Colitis, and their Correlation with Clinical Follow-up Data (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918093, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.