NCT07343115

Brief Summary

Studying familial forms of systemic scleroderma offers several advantages:

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 2, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

Systemic Scleroderma

Keywords

Systemic SclerodermaFamilial Systemic SclerodermaAutoimmune disease

Outcome Measures

Primary Outcomes (1)

  • Description of the clinical characteristics of patients with familial systemic scleroderma

    The clinical presentation describes how the disease manifests in patients: the symptoms, their severity, and their progression.

    Up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects diagnosed with systemic scleroderma by a clinician

You may qualify if:

  • 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

You may not qualify if:

  • \- Subject who has expressed opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine interne et Immunologie clinique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, SystemicAutoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesImmune System Diseases

Central Study Contacts

Aurélien GUFFROY, MD

CONTACT

33 3 69 5512 23aurelien.guffroy@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

September 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 2, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(1)