Crohn's DiseaseNCT04956991
CT Diagnoses in Crohn"s Disease Activity
An observational study of Crohn's Disease, run by Peking University Third Hospital.
Trial summary
The study focused on the clinical value of CT in assessing the activity of Crohn's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn's Disease
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2011to 30 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Crohn"s disease with complete CT and clinical data
Who may be able to join
- Crohn's disease patients with confirmed endoscopic or pathological examination results
- Complete laboratory data such as CRP, erythrocyte sedimentation rate, etc.
Who cannot join
- Related inspection results are not complete
- The interval between endoscopic and laboratory examination results exceeds 2 months
About this study
Official title: Applications of CT in Differentiating Crohn's Disease Activity
The study focused on the clinical value of CT in assessing the activity of Crohn's disease.
Read the detailed description
"Crohn's disease is an inflammatory disease with non-specific clinical manifestations. The lesions are more common in the ileocecal area and the end of the ileum, and also can affect the entire digestive tract. In recent years, the domestic incidence of Crohn's disease has been increasing. At present, CT diagnosis still lacks the gold standard and requirescombination of clinical manifestations, endoscopic examination, imaging examination and laboratory examination results. CT has showed advantages of non-invasive inspection, fast imaging speed, high tissue density resolution, and strong patient acceptability. In addition, the examination can clearly show the internal and external tissue structure of the digestive tract, which has been widely used in the diagnosis and activity evaluation of Crohn's disease.
In order to clarify the clinical value of CT in assessing the activity of Crohn's disease, this study mainly used retrospective analysis of the CT manifestations and clinical data of patients with Crohn's disease to explore the clinical value of CT in assessing the activity of patients with Crohn's disease."
- Conditions
- Crohn's Disease
- 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 |
|---|---|---|
| CDAI≤220 | According to the Crohn's disease activity index (CDAI) scores, all the patients included in the study were divided into group A (CDAI≤220) | |
| CDAI>220 | According to the Crohn's disease activity index (CDAI) scores, all the patients included in the study were divided into group B (CDAI>220) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's disease activity index (CDAI) scores
Crohn's disease activity index (CDAI) scores
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jun 2011
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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 Peking University Third HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyu Liu, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956991
- Sponsor's protocol ID
- M2018130
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of CT in Differentiating Crohn's Disease Activity
- ClinicalTrials.gov ID
- NCT04956991
- Acronym / sponsor ID
- M2018130
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 9 Jul 2021 (actual)
- 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 study focused on the clinical value of CT in assessing the activity of Crohn's disease.
Detailed description
"Crohn's disease is an inflammatory disease with non-specific clinical manifestations. The lesions are more common in the ileocecal area and the end of the ileum, and also can affect the entire digestive tract. In recent years, the domestic incidence of Crohn's disease has been increasing. At present, CT diagnosis still lacks the gold standard and requirescombination of clinical manifestations, endoscopic examination, imaging examination and laboratory examination results. CT has showed advantages of non-invasive inspection, fast imaging speed, high tissue density resolution, and strong patient acceptability. In addition, the examination can clearly show the internal and external tissue structure of the digestive tract, which has been widely used in the diagnosis and activity evaluation of Crohn's disease.
In order to clarify the clinical value of CT in assessing the activity of Crohn's disease, this study mainly used retrospective analysis of the CT manifestations and clinical data of patients with Crohn's disease to explore the clinical value of CT in assessing the activity of patients with Crohn's disease."
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDAI≤220 | – | –According to the Crohn's disease activity index (CDAI) scores, all the patients included in the study were divided into group A (CDAI≤220) |
| CDAI>220 | – | –According to the Crohn's disease activity index (CDAI) scores, all the patients included in the study were divided into group B (CDAI>220) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Crohn"s disease with complete CT and clinical data
Key inclusion criteria (2 listed)
- Crohn's disease patients with confirmed endoscopic or pathological examination results
- Complete laboratory data such as CRP, erythrocyte sedimentation rate, etc.
Key exclusion criteria (2 listed)
- Related inspection results are not complete
- The interval between endoscopic and laboratory examination results exceeds 2 months
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
Crohn's disease activity index (CDAI) scores
Time frame: 1year
Crohn's disease activity index (CDAI) scores
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 9 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Crohn's Disease
RecruitingPhase 3
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease
Moderately to Severely Active Crohns Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Not yet recruitingPhase 2
Oral N-acetylglucosamine in Crohn's Disease
Crohns Disease
RecruitingPhase 2
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Inflammatory Bowel Diseases, Crohn's Disease
Not yet recruiting
Effects of Different Physical Activity Strategies on Disease Activity of IBD Patients
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
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.
Jianyu Liu study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Peking University Third Hospital.
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 2 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Crohn's disease activity index (CDAI) scores (time frame: 1year). It is what the study was designed to measure, not a finding.
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 9 Jul 2021.