- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350685
Detection and Characteristic of Whipple Diseases in the Great Britany (WHO)
Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma.
Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.
None of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis.
As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma whipplei is low in this context.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49933
- CHU d'Angers
-
Brest, France, 29609
- CHRU de Brest
-
Le Mans, France, 72037
- CH Le Mans
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Nantes, France, 44093
- CHU de Nantes
-
Orleans, France, 450000
- CH d'Orleans
-
Poitiers, France, 86 021
- CHU de Poitiers
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Rennes, France, 35000
- CHU de Rennes
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Tours, France, 37044
- CHU de Tours
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult
- patient with at least a screening test for Whipple'disease
- participation agreement,
Exclusion Criteria:
- No test for Whipple'disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Classic Whipple's disease (CWD)
Classic Whipple's disease (CWD), defined as
|
Focal Whipple's disease (FWD)
Focal Whipple's disease (FWD), defined as
|
Chronic T. whipplei-associated arthritis (CTWA)
Chronic T. whipplei-associated arthritis (CTWA) defined as chronic arthritis and
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients diagnosed as whipple's disease
Time Frame: Day 0 ( Date of diagnostic)
|
Diagnosis of Whipple's disease based on
|
Day 0 ( Date of diagnostic)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of test performed in each centre
Time Frame: Day 0 (Date of diagnostic)
|
Number of diagnoses according to tests Patients will be divided into three groups Classic Whipple's disease (CWD), defined as :
Focal Whipple's disease (FWD)
Chronic T. whipplei-associated arthritis (CTWA): chronic arthritis and
|
Day 0 (Date of diagnostic)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHO (29BRC17.0179)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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