Prognostic Value of Anti-Ro52 Antibodies in Connective Tissue Diseases (a-Ro52) (a-Ro52)

December 6, 2019 updated by: Central Hospital, Nancy, France

Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases

Anti-Ro52 autoantibodies can be detected in patients with several autoimmune diseases. Clinical significance of anti-Ro52 is controversial. The presence of anti-Ro52 may be a factor associated with disease severity (interstitial lung disease, vasculopathy) and cancers. The aim of this study is to assess interstitial lung disease and vasculopathy prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Dijon, France
        • Completed
        • Central Hospital
      • Lille, France
        • Completed
        • Central Hospital
      • Metz, France
        • Recruiting
        • Private hospital
        • Contact:
        • Principal Investigator:
          • François MAURIER, Dr
      • Nancy, France
        • Completed
        • Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with connective tissue disease (differenciated or not) and anti-Ro52 antibodies (as single specificity or associated with other autoantibody specificities) at diagnosis

Description

Inclusion Criteria:

  • Connective tissue disease (differenciated or not)
  • Presence of anti-Ro52 antibodies at diagnosis

Exclusion Criteria:

  • Healthy subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CTD patients with anti-Ro52 antibodies
Connective tissue disease patients with anti-Ro52 antibodies at diagnosis
Other: Follow-up
Clinical data, radiological data and laboratory tests follow-up
CTD patients without anti-Ro52 antibodies
Connective tissue disease patients without anti-Ro52 antibodies at diagnosis
Other: Follow-up
Clinical data, radiological data and laboratory tests follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ILD prevalence
Time Frame: baseline (J0)
Clinical (cough, dyspnea) and/or radiological (tomodensitometry) data
baseline (J0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ILD severity
Time Frame: baseline (J0)
PFT (pulmonary function test): FVC, FEV1, DLCO (percentages of predicted values)
baseline (J0)
Vasculopathy occurence
Time Frame: baseline (J0) and follow-up
Raynaud disease, digital ulcers or gangrene
baseline (J0) and follow-up
Cancer occurence
Time Frame: baseline (J0) and follow-up
baseline (J0) and follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Roland JAUSSAUD, Pr, Central Hospital, Nancy, France
  • Study Director: Paul DECKER, MR, Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS2018/AR052-DECKER/MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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