RecruitingNCT06629194

Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease

Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Utilizing Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population


Sponsor

Mahidol University

Enrollment

84 participants

Start Date

Jun 9, 2024

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study aims to validate scoring systems that help doctors distinguish between two conditions that look very similar on colonoscopy: intestinal tuberculosis (TB) and Crohn's disease. Getting this diagnosis right is critical because the treatments are very different. **You may be eligible if...** - You are 18 years or older - You had a colonoscopy that found ulcers in your small intestine or colon - Tissue samples were sent for TB testing - You were ultimately diagnosed with either intestinal TB or Crohn's disease **You may NOT be eligible if...** - Your intestinal ulcers were caused by a different condition (not TB or Crohn's) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTinterferon 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.


Locations(2)

Assoc. Prof. Julajak Limsrivilai, MD

Bangkok Noi, Bangkok, Thailand

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Thailand

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NCT06629194


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