Inflammatory Bowel Disease (IBD)NCT06705972
Comparing the Accuracy of Different Ultrasound-based Scores to Assess Disease Severity in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD), run by Assiut University.
Trial summary
Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Oct 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sample size was calculated using the sample size calculator for sensitivity and specificity studies described by Dr Lin Naing @ Mohd. Ayub Sadiq (School of Dental Sciences, Universiti Sains Malaysia, Penang, Malaysia). Based on determining the main outcome variabble which is To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients and To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings According to the following inputs: expected sensitivity of the ultrasound in detecting IBD patients = 92%, expected Specificity =75%,*(9)* , desired precision = 6%, Confidence level = 80%. Sample size was 60 cases.Sample size was calculated using the sample size calculator for sensitivity and specificity studies described
Who may be able to join
- Adult patients aged 18-70 Confirmed diagnosis of Crohn's Disease or Ulcerative Colitis based on clinical, endoscopic, and histologic criteria
Who cannot join
- Patients with other gastrointestinal diseases History of colectomy or proctocolectomy: Patients without a colon or rectum, which would limit the ability to assess IBD in those regions using ultrasound
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Martina Mamdouh zekry contact
Marwa mohammed samy, Associate professor contact
About this study
Official title: Comparing the Accuracy of Different Ultrasound -Based Scores to Assess Disease Severity in Patients With Inflammatory Bowel Disease
Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity The aim of research is to compare between different ultrasound based scores used to assess disease severity in patients with inflammatory bowel disease to determine the most accurate score to be validated to use in clinical practice
Read the detailed description
- Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity
- IBD patients require repeat imaging throughout the course of their disease, necessitating a safe, noninvasive, available, and repeatable method. Imaging is required at diagnosis, routine surveillance, and acute flare of disease. Ultrasound imaging meets these demands with a high degree of accuracy and wide patient acceptance. Ultrasound provides high-resolution imaging and is excellent for detailed evaluation of the bowel wall and surrounding soft tissues performed without ionizing radiation with an extremely low risk of adverse contrast events compared to CT and MR Enterography which use ahigh dose of ionizing radiation, making it the frst choice of many Gastroenterologists and overwhelmingly preferred by patients
Several established IUS parameters are assessed during an IUS examination. These include bowel wall thickness (BWT); the stratification of the bowel wall layers, blood flow, luminal diameters, and motility, Additional extraintestinal surrogates to bowel inflammation to assess for include mesenteric fat proliferation and lymphadenopathy ,with proposal of different sonographic scoring systems in this domain to predict disease severity
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- inflammatory bowel disease,ultrasound,scoring
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare efficacy of different ultrasound scores to assess disease severity in IBD patients
To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients.
To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings
.To identify the most reliable and practical ultrasound scoring system for routine clinical use
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Mamdouh Zekry Ayoub, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705972
- Sponsor's protocol ID
- Role of ultrasound in IBD
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rimola J, Torres J, Kumar S, Taylor SA, Kucharzik T. Recent advances in clinical practice: advances in cross-sectional imaging in inflammatory bowel disease. Gut. 2022 Dec;71(12):2587-2597. doi: 10.1136/gutjnl-2021-326562. Epub 2022 Aug 4.
PubMed 35927032Valette PJ, Rioux M, Pilleul F, Saurin JC, Fouque P, Henry L. Ultrasonography of chronic inflammatory bowel diseases. Eur Radiol. 2001;11(10):1859-66. doi: 10.1007/s003300101065.
PubMed 11702118Allocca M, Dell'Avalle C, Craviotto V, Furfaro F, Zilli A, D'Amico F, Bonovas S, Peyrin-Biroulet L, Fiorino G, Danese S. Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study. United European Gastroenterol J. 2022 Mar;10(2):190-197. doi: 10.1002/ueg2.12206. Epub 2022 Mar 1.
PubMed 35233934Dragoni G, Gottin M, Innocenti T, Lynch EN, Bagnoli S, Macri G, Bonanomi AG, Orlandini B, Rogai F, Milani S, Galli A, Milla M, Biagini MR. Correlation of Ultrasound Scores with Endoscopic Activity in Crohn's Disease: A Prospective Exploratory Study. J Crohns Colitis. 2023 Oct 20;17(9):1387-1394. doi: 10.1093/ecco-jcc/jjad068.
PubMed 37023010Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129.
PubMed 32614386
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Accuracy of Different Ultrasound -Based Scores to Assess Disease Severity in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06705972
- Acronym / sponsor ID
- Role of ultrasound in IBD
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- inflammatory bowel disease,ultrasound,scoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 26 Nov 2024 (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.
Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity The aim of research is to compare between different ultrasound based scores used to assess disease severity in patients with inflammatory bowel disease to determine the most accurate score to be validated to use in clinical practice
Detailed description
- Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity
- IBD patients require repeat imaging throughout the course of their disease, necessitating a safe, noninvasive, available, and repeatable method. Imaging is required at diagnosis, routine surveillance, and acute flare of disease. Ultrasound imaging meets these demands with a high degree of accuracy and wide patient acceptance. Ultrasound provides high-resolution imaging and is excellent for detailed evaluation of the bowel wall and surrounding soft tissues performed without ionizing radiation with an extremely low risk of adverse contrast events compared to CT and MR Enterography which use ahigh dose of ionizing radiation, making it the frst choice of many Gastroenterologists and overwhelmingly preferred by patients
Several established IUS parameters are assessed during an IUS examination. These include bowel wall thickness (BWT); the stratification of the bowel wall layers, blood flow, luminal diameters, and motility, Additional extraintestinal surrogates to bowel inflammation to assess for include mesenteric fat proliferation and lymphadenopathy ,with proposal of different sonographic scoring systems in this domain to predict disease severity
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size was calculated using the sample size calculator for sensitivity and specificity studies described by Dr Lin Naing @ Mohd. Ayub Sadiq (School of Dental Sciences, Universiti Sains Malaysia, Penang, Malaysia). Based on determining the main outcome variabble which is To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients and To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings According to the following inputs: expected sensitivity of the ultrasound in detecting IBD patients = 92%, expected Specificity =75%,*(9)* , desired precision = 6%, Confidence level = 80%. Sample size was 60 cases.Sample size was calculated using the sample size calculator for sensitivity and specificity studies described
Key inclusion criteria (1 listed)
- Adult patients aged 18-70 Confirmed diagnosis of Crohn's Disease or Ulcerative Colitis based on clinical, endoscopic, and histologic criteria
Key exclusion criteria (1 listed)
- Patients with other gastrointestinal diseases History of colectomy or proctocolectomy: Patients without a colon or rectum, which would limit the ability to assess IBD in those regions using ultrasound
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
To compare efficacy of different ultrasound scores to assess disease severity in IBD patients
Time frame: Baseline
To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients. To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings .To identify the most reliable and practical ultrasound scoring system for routine clinical use
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 26 Nov 2024.
- Results publication: PubMed 35927032Rimola J, Torres J, Kumar S, Taylor SA, Kucharzik T. Recent advances in clinical practice: advances in cross-sectional imaging in inflammatory bowel disease. Gut. 2022 Dec;71(12):2587-2597. doi: 10.1136/gutjnl-2021-326562. Epub 2022 Aug 4.
- Results publication: PubMed 11702118Valette PJ, Rioux M, Pilleul F, Saurin JC, Fouque P, Henry L. Ultrasonography of chronic inflammatory bowel diseases. Eur Radiol. 2001;11(10):1859-66. doi: 10.1007/s003300101065.
- Results publication: PubMed 35233934Allocca M, Dell'Avalle C, Craviotto V, Furfaro F, Zilli A, D'Amico F, Bonovas S, Peyrin-Biroulet L, Fiorino G, Danese S. Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study. United European Gastroenterol J. 2022 Mar;10(2):190-197. doi: 10.1002/ueg2.12206. Epub 2022 Mar 1.
- Results publication: PubMed 37023010Dragoni G, Gottin M, Innocenti T, Lynch EN, Bagnoli S, Macri G, Bonanomi AG, Orlandini B, Rogai F, Milani S, Galli A, Milla M, Biagini MR. Correlation of Ultrasound Scores with Endoscopic Activity in Crohn's Disease: A Prospective Exploratory Study. J Crohns Colitis. 2023 Oct 20;17(9):1387-1394. doi: 10.1093/ecco-jcc/jjad068.
- Results publication: PubMed 32614386Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129.
- 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.
Martina Mamdouh zekry contact
Marwa mohammed samy, Associate professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD), 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 26 Nov 2024. 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 Martina Mamdouh zekry (drmartinamamdouh9@gmail.com ext. +2001274675018, drmartinamamdouh9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare efficacy of different ultrasound scores to assess disease severity in IBD patients (time frame: Baseline). 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 NCT06705972, which also lists 5 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 26 Nov 2024.