Crohn's DiseaseNCT01392365
Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
An observational study of Crohn's Disease and Intestinal Tuberculosis, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease, Intestinal Tuberculosis
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Feb 2015
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Crohn's Disease, Intestinal Tuberculosis
- Keywords
- Crohn's disease, Intestinal tuberculosis, Diagnosis, Differential
- Medical subject headings
- Crohn Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final diagnosis (Intestinal tuberculosis or Crohn's disease)
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 tuberculosis or Crohn's disease will be constructed in the development group and will be validated in the validation group.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byong Duk Ye, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392365
- Sponsor's protocol ID
- 2011-0380
- Status last verified
- Jun 2016
- First submitted
- 11 Jul 2011
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19240705Makharia 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 20087333Lee 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. doi: 10.1055/s-2006-924996. Epub 2006 Apr 27.
PubMed 16673312Bae JH, Park SH, Ye BD, Kim SO, Cho YK, Youn EJ, Lee HS, Hwang SW, Yang DH, Kim KJ, Byeon JS, Myung SJ, Yang SK. Development and Validation of a Novel Prediction Model for Differential Diagnosis Between Crohn's Disease and Intestinal Tuberculosis. Inflamm Bowel Dis. 2017 Sep;23(9):1614-1623. doi: 10.1097/MIB.0000000000001162.
PubMed 28682807
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prediction Model for Differential Diagnosis Between Intestinal Tuberculosis and Crohn's Disease
- ClinicalTrials.gov ID
- NCT01392365
- Acronym / sponsor ID
- 2011-0380
- Conditions
- Crohn's Disease, Intestinal Tuberculosis
- Keywords
- Crohn's disease, Intestinal tuberculosis, Diagnosis, Differential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Jul 2011 (estimated)
- 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.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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\
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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 tuberculosis or Crohn's disease will be constructed in the development group and will be validated in the validation group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Results publication: PubMed 19240705Almadi 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.
- Results publication: PubMed 20087333Makharia 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.
- Results publication: PubMed 16673312Lee 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. doi: 10.1055/s-2006-924996. Epub 2006 Apr 27.
- Derived from this study: PubMed 28682807Bae JH, Park SH, Ye BD, Kim SO, Cho YK, Youn EJ, Lee HS, Hwang SW, Yang DH, Kim KJ, Byeon JS, Myung SJ, Yang SK. Development and Validation of a Novel Prediction Model for Differential Diagnosis Between Crohn's Disease and Intestinal Tuberculosis. Inflamm Bowel Dis. 2017 Sep;23(9):1614-1623. doi: 10.1097/MIB.0000000000001162.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Intestinal Tuberculosis, run by Asan Medical Center at 1 site in South Korea.
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 0 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392365, which also lists 4 linked publications.
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 14 Jun 2016.