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| Name | Class |
|---|---|
| British Society of Gastrointestinal and Abdominal Radiology (BSGAR) | UNKNOWN |
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This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse quickly (disease comes back) after stopping biologic medication. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients.
This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse (disease comes back) after stopping biologic medication when clinically well. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients.
Using a network of British Society of Gastrointestinal and Abdominal Radiology (BSGAR) affiliated NHS hospitals, up to 200 patients who have stopped biologic treatment and recently underwent MRE as part of usual care will be identified. Detailed analysis will be performed on these MRI scans using scores measuring residual bowel inflammation, and retrospectively collect standard clinical data such as blood, stool and colonoscopy results. Using hospital records (accessed by each local care team before being pseudoanonymised) the study will see what happened to patients after one year, specifically if they relapsed or remained well off the biologics.
Based on a literature review, the most promising predictors of early relapse will be identified, such as blood/stool tests, to build a statistical model that provides the risk of a patient relapsing within one year. MRE scores will be added to this model to see if it improves the ability to predict relapse.
The results of the study could form part of a clinical decision support tool to help risk stratify patients and improved joint management decision making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's Disease patients stopping biologic therapy | Crohn's Disease patients stopping biologic therapy and undergoing MR Enterography 3 months before or 1 month after this decision as part of standard clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR Enterography (MRE) | Diagnostic Test | MRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy | To develop and internally evaluate a multivariable prediction model for early (within one year) disease relapse in patients stopping biological therapy, combining pre-existing clinical parameters with MRE parameters and compare to a baseline model incorporating clinical variables alone | 1 year prediction |
| Measure | Description | Time Frame |
|---|---|---|
| Establish which individual MRE finding/combination of findings best predicts disease relapse after stopping biologic therapy, including complete transmural healing. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the association of biologic treatment duration on relapse at one year. | 1 year | |
| To investigate the association of concurrent medication use after stopping biologics on relapse at one year. | 1 year |
Inclusion Criteria:
Definition of clinical remission: There is no agreed consensus on how clinical remission is defined and practice differs between hospitals and patients. To mirror current clinical practice, no strict definition of clinical remission will therefore be used. Detailed clinical parameters the time of stopping biologic agents will be collected.
Exclusion Criteria:
<16 years of age
Non-biological therapy, unless part of combination therapy with biologic agents
Biological therapy stopped for other reasons e.g. loss of effect, side effects
Resection of diseased segment(s) after MRE but before stopping biologic agent.
No MRE with the time window defined by eligibility criteria
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Crohn's disease patients will be identified after the clinical decision to stop biologics including during outpatient clinics, multidisciplinary meetings, any local patient databases, and imaging investigation requests.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maira Hameed | Contact | 020 7679 9274 | maira.hameed@ucl.ac.uk | |
| Elizabeth Isaac | Contact | 02034474415 | e.isaac@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Maira Hameed | University College London Centre for Medical Imaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital | Recruiting | London | NW1 2PG | United Kingdom |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| To establish the most common criteria for diagnosing disease relapse used by multidisciplinary consensus panels. | 1 year |
| D007410 | Intestinal Diseases |