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Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria

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ClinicalTrials.gov Identifier: NCT03133949
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date April 13, 2017
First Posted Date April 28, 2017
Last Update Posted Date April 28, 2017
Actual Study Start Date July 8, 2010
Estimated Primary Completion Date July 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2017)
Analyze the management of patients with aortic and retroperitoneal fibrosis [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria
Official Title Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria
Brief Summary

Inflammatory aortitis probably represents a heterogeneous group, and the clinical experience accumulated over the last ten years, shared by the experts of the subject, is that the initial clinical, biological or radiological characteristics should make it possible to differentiate them and dismember the Nosological field.

This will be an essential first step before studying prognosis, risk factors, and therapeutic options.

The search for diagnostic criteria on a large series, similar to the study of classification of vascularites of the ACR in 1990, should make it possible to homogenize the diagnoses for the different teams working on the subject, and to begin work Collaborations, which alone can improve patient care in the future.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

All patients with idiopathic inflammatory aortitis or retroperitoneal fibrosis.

Three focus groups will be constituted:

Group 1: it will include all cases of non-idiopathic inflammatory aortitis followed in the participating centers over the last 15 years, Group 2: it will include patients with non-inflammatory aortic conditions (aneurysm, atheroma, annulo-ectasitic aortic disease).

Group 3: it will include patients without aortic pathology matched by age and sex, having a thoracoabdominal scanner or MRI in the participating centers.

Condition
  • Idiopathic Aortitis
  • Retroperitoneal Fibrosis
Intervention Other: Establish the clinical, biological and radiological characteristics of patients
Establish the clinical, biological and radiological characteristics of patients
Study Groups/Cohorts
  • Patients with idiopathic inflammatory aortitis
    Intervention: Other: Establish the clinical, biological and radiological characteristics of patients
  • a group of witnesses
    Intervention: Other: Establish the clinical, biological and radiological characteristics of patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2017)
206
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 8, 2020
Estimated Primary Completion Date July 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Cases :

    • All cases of idiopathic aortitis and retroperitoneal fibrosis followed in participating centers over the past 15 years will be collected.
  • Witnesses :

    • Group 1: non-idiopathic inflammatory aortitis: all cases of inflammatory aortitis (apart from idiopathic aortites and isolated retroperitoneal fibrosis) followed in the participating centers over the last 15 years will be collected.
    • Group 2: subjects with noninflammatory aortic disease, atheromatous type or annulo-ectasitic disease, matched by age and sex with cases. This group will be used to define the differential characteristics between idiopathic aortitis and noninflammatory aortic pathology.
    • Group 3: This group will include control subjects aimed at defining radiological normality criteria according to age and sex. As the images are machine-dependent, group 3 controls will be randomly selected from the radiology departments that have performed the scanner or MRI of the corresponding control.

Exclusion Criteria:

  • Patients under 18 years of age
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jean SCHMIDT, PhD +33322668230 schmidt.jean@chu-amiens.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03133949
Other Study ID Numbers PHRCIR09-DR-SCHMIDT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date April 2017