Familial Systemic Scleroderma (SCLERO)

January 6, 2026 updated by: University Hospital, Strasbourg, France

Studying familial forms of systemic scleroderma offers several advantages:

  1. To better understand the pathophysiology of a complex autoimmune disease based on "extreme" cases (familial forms);
  2. To identify potential molecular markers predictive of disease progression;
  3. To identify potential pathophysiological targets for developing new therapies, particularly relevant in severe and refractory forms of the disease.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

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 Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Médecine interne et Immunologie clinique - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Aurélien GUFFROY, MD
        • Principal Investigator:
          • Jeannne MALLICK, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subjects diagnosed with systemic scleroderma by a clinician

Description

Inclusion Criteria:

  • Adult subjects (≥ 18 years of age)
  • Subjects diagnosed with systemic scleroderma by a clinician (including limited, diffuse, and sine scleroderma SSc, as well as overlap syndromes with myositis) and meeting at least the VEDOSS criteria: Raynaud's phenomenon + 1 other criterion from among: sausage fingers, antinuclear antibodies, scleroderma-specific antibodies (anti-centromere, anti-RNApolIII, anti-ScL70), capillaroscopic abnormalities
  • At least one first-degree relative with systemic scleroderma meeting the same criteria

Exclusion Criteria:

- Subject who has expressed opposition to participating in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the clinical characteristics of patients with familial systemic scleroderma
Time Frame: Up to 12 months

The clinical presentation describes how the disease manifests in patients:

the symptoms, their severity, and their progression.
Up to 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

September 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 2, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9820

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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