Crohn DiseaseNCT06629194
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease
An observational study of Crohn Disease and Intestinal Tuberculosis, run by Mahidol University at 2 sites in Thailand.
Trial summary
Differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Intestinal Tuberculosis, Differential Diagnosis
- What is being tested?
- interferon gamma releasing assay (IGRA)
- Type of treatment
- Injection or infusion
- How many people
- 84 participants
- Where
- 2 sitesThailand
- Study dates
- 9 Jun 2024to 1 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had clinical symptoms suspicious of either Crohn\'s disease or intestinal tuberculosis are eligible.
Who may be able to join
- Patients ages 18 years or older
- Undergoing colonoscopy and found ileal or colonic ulcers
- Have ileal and/or colonic tissue sent for mycobacterial tests, including stain for AFB, PCR, and culture
- Diagnosed with either intestinal tuberculosis or Crohn's disease a. Criteria of intestinal tuberculosis diagnosis includes any of following: i. Presence of caseating granuloma on pathological examination of specimens ii. Presence of acid-fast bacilli on pathological examination of specimens iii. PCR positive for Mycobacterium tuberculosis iv. Tissue culture growing organisms consistent with Mycobacterium tuberculosis v. Negative results in i to iv but response to empirical treatment with antituberculous therapy All are required to have clinical and endoscopic response to antituberculous therapy (ATT) treatment b. Diagnosis of Crohn's disease is based on clinical, endoscopic, pathological, and/or radiological findings which is confirmed by clinical \& endoscopic response to Crohn's disease treatment
Who cannot join
- 1. Patients with ileal/colonic ulcers caused by other diseases
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Not yet recruiting
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
Julajak Limsrivilai, MD, +66814968895, alimsrivilai@gmail.com
Julajak Limsrivilai
- Recruiting
Assoc. Prof. Julajak Limsrivilai, MD
Bangkok Noi, Bangkok, 10700
Onuma Sattayalertyanyong, +66816165390, onuma.gimed@gmail.com
About this study
Official title: Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Utilizing Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population
Differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients with ITB are misdiagnosed with CD, and are prescribed immunosuppressive therapy. However, treatment with ATT has many side effects and may delay treatment in patients with CD, and this may cause severe relapse and developing complications. Many studies found that some clinical, endoscopy, pathology, radiology, and serology findings can help to improve diagnostic accuracy in these patients. However, no single diagnostic parameter can distinguish between CD and ITB. As a result, many models were developed that include various factors and modalities, and many of those models have been reported to have high performance. However, the number of studies performed to validate those models externally was limited. Correspondingly, this study is designed to prospectively validate models that integrate more advanced parameters (e.g., IGRA, CT enterography findings) with clinical, endoscopic, or pathological findings. However, it aims mainly to evaluate the model integrating clinical, endoscopic, and serological variables since CT enterography and pathological interpretation require experienced radiologists and pathologists but they are not available in many centers.
Read the detailed description
Crohn's disease (CD) incidence has been increasing in Asia over the last few decades [1]. Moreover, differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The 5.3- 37.5% sensitivity of acid-fast bacilli (AFB) specimen staining, the 23%-46% sensitivity of mycobacterial culture, and the 36.4-67.9% sensitivity of tissue polymerase chain reaction (PCR) are all too low to confidently distinguish between these two conditions and exclude a diagnosis of ITB. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients with ITB are misdiagnosed with CD, and are prescribed immunosuppressive therapy. However, treatment with ATT has many side effects and may delay treatment in patients with CD, and this may cause severe relapse and developing complications. In response, many studies were conducted to identify and classify characteristics that can help to distinguish between these two diseases. Those studies found that some clinical, endoscopy, pathology, radiology, and serology findings can help to improve diagnostic accuracy in these patients. However, no single diagnostic parameter can distinguish between CD and ITB. As a result, many models were developed that include various factors and modalities, and many of those models have been reported to have high performance. However, the number of studies performed to externally validate those models was limited.
To address this inadequacy, J Limsrivilai, et al. conducted a multicenter retrospective study comparing the ability of each different diagnostic model consisting of different combinations of basic clinical, endoscopic, and pathologic parameters affordable to resource-limited healthcare settings at differentiating CD and ITB patients. In the study, several differentiating models were included and applied to a cohort of 590 patients from Thailand and Hong Kong to validate the models. The results from the study concluded that the accuracy of a differentiating model is directly correlated with the number of diagnostic modalities and variables of the model with the ITBvsCD-CEP model, which includes 22 variables from clinical, endoscopy, and pathology parameters, demonstrating the highest AUROC as high as 0.887. Although the model demonstrated such impressive diagnostic ability, its application in real-life clinical practice has remained controversial as around 10% of ITB patients would still be misdiagnosed and thus receive the wrong treatments. Integrating more diagnostic modalities, such as interferon gamma-releasing assay (IGRA) and CT enterography, may be helpful.
Correspondingly, this study is designed to prospectively validate models that integrate more advanced parameters (e.g., IGRA, CT enterography findings) with clinical, endoscopic, or pathological findings. However, it aims mainly to evaluate the model integrating clinical, endoscopic, and serological variables since CT enterography and pathological interpretation require experienced radiologists and pathologists but they are not available in many centers.
- Being tested
- interferon gamma releasing assay (IGRA)
- Keywords
- Intestinal tuberculosis, Crohn Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon gamma releasing assay (IGRA)Diagnostic test
All patients who suspected CD or TB will be tested for interferon-gamma releasing assay. An interferon-gamma release assay is a blood test that measures the body\'s immune response to Mycobacterium tuberculosis, the bacteria that causes tuberculosis.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | Patients who were diagnosed Crohn's disease
- Diagnosis of Crohn's disease is based on clinical, endoscopic, pathological, and/or radiological findings which is confirmed by clinical \& endoscopic response to Crohn's disease treatment Receives: Diagnostic Test: interferon gamma releasing assay (IGRA) | |
| Intestinal tuberculosis | Patients who were diagnosed intestinal tuberculosis.
* Criteria of intestinal tuberculosis diagnosis includes any of following:
i. Presence of caseating granuloma on pathological examination of specimens ii. Presence of acid-fast bacilli on pathological examination of specimens iii. PCR positive for Mycobacterium tuberculosis iv. Tissue culture growing organisms consistent with Mycobacterium tuberculosis v. Negative results in i to iv but response to empirical treatment with antituberculous therapy
* All are required to have clinical and endoscopic response to antituberculous therapy (ATT) treatment Receives: Diagnostic Test: interferon gamma releasing assay (IGRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the ITBvsCD model
The ITBvsCD model performance in differentiating Crohns disease from intestinal tuberculosis will be evaluated by area under the receiver operating characteristic (ROC) curve.
Measured: with 4 weeks of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start9 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Association for the Study of Intestinal Diseases
- Responsible party
- Principal investigator, Julajak Limsrivilai, Mahidol University
- Investigators
- Julajak Limsrivilai, Principal investigator, Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629194
- Sponsor's protocol ID
- Si212/2024
- Status last verified
- Oct 2024
- First submitted
- 9 Jun 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Utilizing Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population
- ClinicalTrials.gov ID
- NCT06629194
- Acronym / sponsor ID
- Si212/2024
- Keywords
- Intestinal tuberculosis, Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Korean Association for the Study of Intestinal Diseases
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Oct 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.
Differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients with ITB are misdiagnosed with CD, and are prescribed immunosuppressive therapy. However, treatment with ATT has many side effects and may delay treatment in patients with CD, and this may cause severe relapse and developing complications. Many studies found that some clinical, endoscopy, pathology, radiology, and serology findings can help to improve diagnostic accuracy in these patients. However, no single diagnostic parameter can distinguish between CD and ITB. As a result, many models were developed that include various factors and modalities, and many of those models have been reported to have high performance. However, the number of studies performed to validate those models externally was limited. Correspondingly, this study is designed to prospectively validate models that integrate more advanced parameters (e.g., IGRA, CT enterography findings) with clinical, endoscopic, or pathological findings. However, it aims mainly to evaluate the model integrating clinical, endoscopic, and serological variables since CT enterography and pathological interpretation require experienced radiologists and pathologists but they are not available in many centers.
Detailed description
Crohn's disease (CD) incidence has been increasing in Asia over the last few decades [1]. Moreover, differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The 5.3- 37.5% sensitivity of acid-fast bacilli (AFB) specimen staining, the 23%-46% sensitivity of mycobacterial culture, and the 36.4-67.9% sensitivity of tissue polymerase chain reaction (PCR) are all too low to confidently distinguish between these two conditions and exclude a diagnosis of ITB. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients with ITB are misdiagnosed with CD, and are prescribed immunosuppressive therapy. However, treatment with ATT has many side effects and may delay treatment in patients with CD, and this may cause severe relapse and developing complications. In response, many studies were conducted to identify and classify characteristics that can help to distinguish between these two diseases. Those studies found that some clinical, endoscopy, pathology, radiology, and serology findings can help to improve diagnostic accuracy in these patients. However, no single diagnostic parameter can distinguish between CD and ITB. As a result, many models were developed that include various factors and modalities, and many of those models have been reported to have high performance. However, the number of studies performed to externally validate those models was limited.
To address this inadequacy, J Limsrivilai, et al. conducted a multicenter retrospective study comparing the ability of each different diagnostic model consisting of different combinations of basic clinical, endoscopic, and pathologic parameters affordable to resource-limited healthcare settings at differentiating CD and ITB patients. In the study, several differentiating models were included and applied to a cohort of 590 patients from Thailand and Hong Kong to validate the models. The results from the study concluded that the accuracy of a differentiating model is directly correlated with the number of diagnostic modalities and variables of the model with the ITBvsCD-CEP model, which includes 22 variables from clinical, endoscopy, and pathology parameters, demonstrating the highest AUROC as high as 0.887. Although the model demonstrated such impressive diagnostic ability, its application in real-life clinical practice has remained controversial as around 10% of ITB patients would still be misdiagnosed and thus receive the wrong treatments. Integrating more diagnostic modalities, such as interferon gamma-releasing assay (IGRA) and CT enterography, may be helpful.
Correspondingly, this study is designed to prospectively validate models that integrate more advanced parameters (e.g., IGRA, CT enterography findings) with clinical, endoscopic, or pathological findings. However, it aims mainly to evaluate the model integrating clinical, endoscopic, and serological variables since CT enterography and pathological interpretation require experienced radiologists and pathologists but they are not available in many centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | Diagnostic Test: interferon gamma releasing assay (IGRA)Patients who were diagnosed Crohn's disease - Diagnosis of Crohn's disease is based on clinical, endoscopic, pathological, and/or radiological findings which is confirmed by clinical \& endoscopic response to Crohn's disease treatment |
| Intestinal tuberculosis | – | Diagnostic Test: interferon gamma releasing assay (IGRA)Patients who were diagnosed intestinal tuberculosis. * Criteria of intestinal tuberculosis diagnosis includes any of following: i. Presence of caseating granuloma on pathological examination of specimens ii. Presence of acid-fast bacilli on pathological examination of specimens iii. PCR positive for Mycobacterium tuberculosis iv. Tissue culture growing organisms consistent with Mycobacterium tuberculosis v. Negative results in i to iv but response to empirical treatment with antituberculous therapy * All are required to have clinical and endoscopic response to antituberculous therapy (ATT) treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had clinical symptoms suspicious of either Crohn\'s disease or intestinal tuberculosis are eligible.
Key inclusion criteria (4 listed)
- Patients ages 18 years or older
- Undergoing colonoscopy and found ileal or colonic ulcers
- Have ileal and/or colonic tissue sent for mycobacterial tests, including stain for AFB, PCR, and culture
- Diagnosed with either intestinal tuberculosis or Crohn's disease a. Criteria of intestinal tuberculosis diagnosis includes any of following: i. Presence of caseating granuloma on pathological examination of specimens ii. Presence of acid-fast bacilli on pathological examination of specimens iii. PCR positive for Mycobacterium tuberculosis iv. Tissue culture growing organisms consistent with Mycobacterium tuberculosis v. Negative results in i to iv but response to empirical treatment with antituberculous therapy All are required to have clinical and endoscopic response to antituberculous therapy (ATT) treatment b. Diagnosis of Crohn's disease is based on clinical, endoscopic, pathological, and/or radiological findings which is confirmed by clinical \& endoscopic response to Crohn's disease treatment
Key exclusion criteria (1 listed)
- 1. Patients with ileal/colonic ulcers caused by other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon gamma releasing assay (IGRA)All patients who suspected CD or TB will be tested for interferon-gamma releasing assay. An interferon-gamma release assay is a blood test that measures the body\'s immune response to Mycobacterium tuberculosis, the bacteria that causes tuberculosis. | Diagnostic test | Crohn's disease, Intestinal tuberculosis |
Primary outcome
Accuracy of the ITBvsCD model
Time frame: with 4 weeks of colonoscopy
The ITBvsCD model performance in differentiating Crohns disease from intestinal tuberculosis will be evaluated by area under the receiver operating characteristic (ROC) curve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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. This study is not recruiting at the moment.
Julajak Limsrivilai principal investigator
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Intestinal Tuberculosis, run by Mahidol University at 2 sites in Thailand.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julajak Limsrivilai (+66814968895, alimsrivilai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the ITBvsCD model (time frame: with 4 weeks of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.