Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629194
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-09
Brief Title:
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohns Disease Utilizing Clinical Endoscopic and Interferon-gamma Releasing Assay in Asian Population
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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:
Crohns 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 53- 375 sensitivity of acid-fast bacilli AFB specimen staining the 23-46 sensitivity of mycobacterial culture and the 364-679 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 0887 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 eg 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
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 0887 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None