Disease Course in an IBD Cohort in the Era of Biological Treatment
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | November 7, 2011 | ||||||||||||||||
| Last Updated Date | November 9, 2011 | ||||||||||||||||
| Start Date ICMJE | October 2011 | ||||||||||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01468090 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Disease Course in an IBD Cohort in the Era of Biological Treatment | ||||||||||||||||
| Official Title ICMJE | Disease Course in an IBD Cohort in the Era of Biological Treatment. Characterization of Early Predictors of Outcome and Identification of Patients in Early Need of Biological Treatment Based on an Unselected Consecutive Cohort After Seven Years Follow-up | ||||||||||||||||
| Brief Summary | The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort is established after the implementation of biological agents in the treatment of IBD and the investigators hypothesis is that a) Severe disease course in IBD can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) Introduction of biological treatment changes the course of disease in IBD and reduces the need of surgical procedures. Methods: Medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior will be evaluated. At outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. The Montreal classification, The Harvey & Bradshaw's activity index (CD) and the SCAAI score (UC) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood and faeces will be retained for biobank |
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| Sampling Method | Non-Probability Sample | ||||||||||||||||
| Study Population | 562 patients diagnosed with Crohn's disease, Ulcerative colitis or indeterminant colitis in 2003-2004 i Copenhagen City and County and registered in a database. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||||||
| Study Group/Cohort (s) | Disease course
562 patients diagnosed with Crohn's disease (209), ulcerative colitis (326) or indeterminant colitis (27) in the period of 1st of January 2003 to 31st of December 2004 in Copenhagen City and County (an area covering 23% of the Danish population). |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||||||||||
| Enrollment ICMJE | 562 | ||||||||||||||||
| Estimated Completion Date | April 2014 | ||||||||||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Denmark | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01468090 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 562_2003_2004 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Marianne Vester-Andersen, Hvidovre University Hospital | ||||||||||||||||
| Study Sponsor ICMJE | Hvidovre University Hospital | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Hvidovre University Hospital | ||||||||||||||||
| Verification Date | November 2011 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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