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Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy (EchoSpA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00794404
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : October 31, 2016
Sponsor:
Collaborators:
Groupe Français d'Etude Génétique des Spondylarthropathies
French Society of Rheumatology
Information provided by (Responsible Party):
Dr Maria-Atonietta D'AGOSTINO, Groupe Français d'Etude Génétique des Spondylarthropathies

Tracking Information
First Submitted Date November 19, 2008
First Posted Date November 20, 2008
Last Update Posted Date October 31, 2016
Study Start Date December 2004
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00794404 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy
Official Title Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy
Brief Summary The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis
Detailed Description Spondylarthritis (SPA) are the second most frequent inflammatory rheumatic disorders and, because it starts early in life and has a chronic progressive course, the impact of this disease on health resources and patient's life quality can be important. Because the characteritic signs of SPA, like radiological evidence of sacro-iliitis, appear late in time, the lag time between the onset first signs of SPA for the patient and the confirmed diagnosis can be very long (up to 8 years). Previous studies proved that patients who are affected by SPA are showing abnormal vascularization of peripheral enthesis more frequently than patients affected by other rheumatic diseases. Ultrasonography in B mode combined with power Doppler (PDUS) is a non invasive and highly sensitive toll which can detect enthesitis and abnormal vsacularization even for the patients who are not showing yet the evidence of SPA's symptomatology. Using PDUS as a early diagnosis tool could lead to the improvement of diagnostic procedures and therapeutic management of SpA and reduce the cost of diagnosis for patient and health insurances.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Patients with a symptomatology which can lead to a SPA diagnosis but with no confirmed diagnosis yet for any rheumatic didease.
Condition
  • Spondylarthropathy
  • Ankylosing Spondyloarthitis
  • Spondyloarthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Devauchelle-Pensec V, D'Agostino MA, Marion J, Lapierre M, Jousse-Joulin S, Colin D, Chary-Valckenaere I, Marcelli C, Loeuille D, Aegerter P, Guis S, Gaudin P, Breban M, Saraux A; Study Group of Spondylarthritis. Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: results of a prospective multicenter French cohort study. Arthritis Rheum. 2012 May;64(5):1412-9. doi: 10.1002/art.33466.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November¬†19,¬†2008)
489
Original Actual Enrollment Same as current
Actual Study Completion Date December 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients < 50 years old, consulting for spinal inflammatory symptoms > 3 months duration
  • patients consulting for arthritis or tenderness joints > 3 months duration
  • patients < 50 years old consulting for enthesitis or dactylitis > 3 months duration
  • patients with uveitis and HLA-B27 positivity
  • relatives of SpA patients consulting for symptoms suggestive of SpA

Exclusion Criteria:

  • patient with confirmed diagnosis of rheumatic disease (included SpA)
  • patient protected by law (patient <18 years old, pregnant woman)
  • patient who can't atempt the RMI
  • patient who will have difficulties to complete the two years of follow-up
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00794404
Other Study ID Numbers GESPA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr Maria-Atonietta D'AGOSTINO, Groupe Français d'Etude Génétique des Spondylarthropathies
Study Sponsor Dr Maria-Atonietta D'AGOSTINO
Collaborators
  • Groupe Français d'Etude Génétique des Spondylarthropathies
  • French Society of Rheumatology
Investigators
Principal Investigator: D'AGOSTINO Maria-Antonietta, MCUPH Ambroise Paré Hospital
PRS Account Groupe Français d'Etude Génétique des Spondylarthropathies
Verification Date November 2008