Study Identification

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ClinicalTrials.gov PRS DRAFT Receipt (Working Version) Last Update: 06/12/2016 04:25

ClinicalTrials.gov ID: NCT01392365

Study Identification

Unique Protocol ID: 2011-0380

Brief Title: Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

Official Title: Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease

Secondary IDs:

Study Status

Record Verification: June 2016 Overall Status: Completed

Study Start: July 2011

Primary Completion: February 2015 [Actual]

Study Completion: February 2015 [Actual]

Sponsor/Collaborators

Sponsor: Asan Medical Center Responsible Party: Principal Investigator

Investigator: Byong Duk Ye [bye]

Official Title: Associate Professor Affiliation: Asan Medical Center Collaborators:

Oversight

FDA Regulated?: No IND/IDE Protocol?: No

Review Board: Approval Status: Approved Approval Number: 06/14/2011 Board Name: Asan Medical Center IRB Board Affiliation: Asan Medical Center Phone: 82-2-3010-7166

Email: [email protected] Data Monitoring?: No

Plan to Share Data?: No

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Oversight Authorities: Korea: Ministry for Health and Welfare

Study Description

Brief Summary: The aim of this study is to develop a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease.

Detailed Description: Crohn’s disease and intestinal tuberculosis mimic each other in clinical, endoscopic, and histological features. In addition, the yield of microbiological/histological test (AFB stain, caseating granuloma) is not high in clinical setting. Therefore, distinguishing CD from ITB especially in highly endemic areas for TB is challenging. The aim of this study is to develop and to validate a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and Crohn's disease

Conditions

Conditions: Crohn's Disease Intestinal Tuberculosis Keywords: Crohn's disease

Intestinal tuberculosis Diagnosis, Differential

Study Design

Study Type: Observational Observational Study Model: Other

Time Perspective: Prospective Biospecimen Retention: None Retained Biospecimen Description:

Enrollment: 117 [Actual]

Number of Groups/Cohorts: 2

Groups and Interventions

Groups/Cohorts Interventions

Crohn' disease

The group of patients whose final diagnosis is Crohn's disease Intestinal tuberculosis

The group of patients whose final diagnosis is intestinal tuberculosis

Outcome Measures

Primary Outcome Measure:

1. Final diagnosis (Intestinal tuberculosis or Crohn's disease)

[Time Frame: 6 months (In a subset of patients, for diagnosis of intestinal tuberculosis, final colonoscopic evaluation after completion of 6-months anti-tuberculous medication is needed)] [Safety Issue: No]

Patients with suspected diagnosis of intestinal tuberculosis or Crohn's disease will be invited to participate in this study. Study variables including past medical history, clinical symptoms and signs, laboratory variables, radiologic findings (Chest X-ray and small bowel follow-through, colonoscopic features) will be gathered at study enrollment.

Final diagnosis of intestinal tuberculosis or Crohn's disease will be made according to the diagnostic criteria previously described (Lee YJ, et al. Endoscopy 2006;38:592-597). A prediction model using various variables for intestinal

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tuberculosis or Crohn's disease will be constructed in the development group and will be validated in the validation group.

Eligibility

Study Population: Patients suspected to have intestinal tuberculosis or Crohn's disease based on clinical history, symptoms, and/or colonoscopic findings are invited to participate in this study.

Sampling Method: Non-Probability Sample Minimum Age: 16 Years

Maximum Age:

Gender: Both Accepts Healthy Volunteers?: No

Criteria: Final diagnostic criteria:

• Crohn' disease (at least two of the following is met)

1. Clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding

2. Endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease

3. Radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration 4. Macroscopic appearance of bowel-wall induration, mesenteric

lymphadenopathy, and "creeping fat" at laparotomy

5. Pathologic findings of transmural inflammation and/or epithelioid granulomas

• Intestinal tuberculosis(at least one of the following is met) 1. Histologic evidence of caseating granulomas 2. Histologic demonstration of acid-fast bacilli 3. Growth of M. tuberculosis on tissue culture

4. Clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis with proved tuberculosis elsewhere

5. Response to antituberculous therapy without subsequent recurrence in patients with clinical, colonoscopic, radiologic, and/or operative evidence of Intestinal tuberculosis

Exclusion Criteria:

• Refusal to participate in the study

• Age: 15 years or younger

• Comorbidity with acute infectious disease

• Pregnancy

• Previous history of medication including anti-TB drugs, immunosuppressive drugs, and chemotherapeutic agents\

• Use of antibiotics within the previous three months

Contacts/Locations

Study Officials:

Locations: Korea, Republic of Asan Medical Center

Seoul, Korea, Republic of, 138-736

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References

Citations: [Study Results] Almadi MA, Ghosh S, Aljebreen AM. Differentiating intestinal tuberculosis from Crohn's disease: a diagnostic challenge. Am J Gastroenterol.

2009 Apr;104(4):1003-12. doi: 10.1038/ajg.2008.162. Epub 2009 Feb 24. Review.

PubMed 19240705

[Study Results] Makharia GK, Srivastava S, Das P, Goswami P, Singh U, Tripathi M, Deo V, Aggarwal A, Tiwari RP, Sreenivas V, Gupta SD. Clinical, endoscopic, and histological differentiations between Crohn's disease and intestinal tuberculosis. Am J Gastroenterol. 2010 Mar;105(3):642-51. doi: 10.1038/ajg.2009.585. Epub 2010 Jan 19.

PubMed 20087333

[Study Results] Lee YJ, Yang SK, Byeon JS, Myung SJ, Chang HS, Hong SS, Kim KJ, Lee GH, Jung HY, Hong WS, Kim JH, Min YI, Chang SJ, Yu CS. Analysis of colonoscopic findings in the differential diagnosis between intestinal tuberculosis and Crohn's disease. Endoscopy. 2006 Jun;38(6):592-7. Epub 2006 Apr 27.

PubMed 16673312 Links:

Study Data/Documents:

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services