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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Julajak Limsrivilai contact

+66814968895

alimsrivilai@gmail.com

Thailand2 sites, 2 recruiting
  • Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

    Bangkok, 10700

    Julajak Limsrivilai, MD, +66814968895, alimsrivilai@gmail.com

    Julajak Limsrivilai

    Not yet recruiting
  • Assoc. Prof. Julajak Limsrivilai, MD

    Bangkok Noi, Bangkok, 10700

    Onuma Sattayalertyanyong, +66816165390, onuma.gimed@gmail.com

    Recruiting

Other trials in Thailand

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 groups in NCT06629194
Study groupRoleWhat they receive
Crohn's diseasePatients 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 tuberculosisPatients 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.

  1. 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.

  1. First posted8 Oct 2024
  2. Study start9 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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
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

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.

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