Crohn's DiseaseNCT00572780
Can CT Enteroclysis Predict the Outcome of Crohn's Disease
An observational study of Crohn's Disease, run by Indiana University at 1 site in United States.
Trial summary
Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2012
- 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: Crohn's disease patients that have had a CT Enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease will be eligible. Subjects who were later diagnosied with bowel malignancy and subjects with a period of follow-up of less than 1 year(without surgery) will be excluded.
Who may be able to join
- Crohn's disease with CT Enteroclysis during symptomatic treatment
Who cannot join
- Crohn's disease subjects who have had a follow-up less than 1 year, without surgery
- Crohn's disease subjects that were later diagnosed with a bowel malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can CT Enteroclysis Predict the Response to Therapy and Outcome in Patient With Crohn's Disease
Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, CT Enteroclysis
- Medical subject headings
- Crohn 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 |
|---|---|---|
| CTE with CD | Crohn's disease patients who underwent a CT enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael V. Chiorean, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572780
- Sponsor's protocol ID
- 070759
- Status last verified
- Aug 2015
- First submitted
- 11 Dec 2007
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can CT Enteroclysis Predict the Response to Therapy and Outcome in Patient With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00572780
- Acronym / sponsor ID
- 070759
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, CT Enteroclysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Dec 2007 (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.
Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTE with CD | – | –Crohn's disease patients who underwent a CT enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Crohn's disease patients that have had a CT Enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease will be eligible. Subjects who were later diagnosied with bowel malignancy and subjects with a period of follow-up of less than 1 year(without surgery) will be excluded.
Key inclusion criteria (1 listed)
- Crohn's disease with CT Enteroclysis during symptomatic treatment
Key exclusion criteria (2 listed)
- Crohn's disease subjects who have had a follow-up less than 1 year, without surgery
- Crohn's disease subjects that were later diagnosed with a bowel malignancy
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
Not reported in the source record.
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 10 Aug 2015.
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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.
Michael V. Chiorean, M.D. principal investigator
Indiana University
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, run by Indiana University at 1 site in United States.
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 1 inclusion and 2 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 10 Aug 2015. 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 United States. 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.
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 10 Aug 2015.