NCT04265144

Brief Summary

Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to conducting quality research on this disease remains the development of well-documented patient cohorts with reliable biological samples. The main objective of this cohort is to study the natural progression of SSc in a cohort of patients followed over 5 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
97mo left

Started Jun 2020

Longer than P75 for not_applicable

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 Progress43%
Jun 2020Jun 2034

First Submitted

Initial submission to the registry

February 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2034

Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

14 years

First QC Date

February 5, 2020

Last Update Submit

September 3, 2025

Conditions

SclerodermaSystemic Sclerosis

Keywords

Cohort studysystemic sclerosisprognosis

Outcome Measures

Primary Outcomes (1)

  • Change of the main clinical characteristics of scleroderma patients

    Worsening of the SSc according to the onset of a renal crisis (according to arterial hypertension \> 150/85 mm Hg ), a pulmonary arterial hypertension (identified with a right heart catheterization), or an interstitial lung disease (identified with a chest CT-scan).

    At baseline (Day 0) and 60 months after baseline

Secondary Outcomes (7)

  • Proportion of pulmonary arterial hypertension diagnosis in SSc patients

    At baseline (Day 0) and 60 months after baseline

  • Proportion of interstitial lung disease diagnosis in SSc patients

    At baseline (Day 0) and 60 months after baseline

  • Proportion of renal crisis diagnosis in SSc patients

    At baseline (Day 0) and 60 months after baseline

  • Mean of Rodnan score for the evaluation of disease activity for SSc patients, with higher values mean higher disease activity.

    At baseline (Day 0) and 60 months after baseline

  • Mean of Diffusing capacity (DLCO) for the evaluation of disease activity for SSc patients

    At baseline (Day 0) and 60 months after baseline

  • +2 more secondary outcomes

Study Arms (1)

subjects SSc diagnosed

EXPERIMENTAL

Patient with systemic scleroderma according to the American College of Rheumatology (ACR) / EULAR 2013 criteria

Biological: Blood samplesOther: BiopsyOther: Bronchoalveolar samples

Interventions

Blood samplesBIOLOGICAL

62 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

subjects SSc diagnosed
BiopsyOTHER

Skin biopsies only for volunteers among patients

subjects SSc diagnosed
Bronchoalveolar samplesOTHER

50 ml of bronchoalveolar samples if pulmonary flare requires this type of exploration only for volunteers among patients

subjects SSc diagnosed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18 years old
  • Patient with systemic scleroderma according to the ACR/EULAR 2013 criteria, or with a " very early systemic sclerosis " defined by the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
  • Person affiliated or benefiting from a social security scheme.

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Patient under guardianship, curatorship or any other legal protection regime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, DiffuseScleroderma, Systemic

Interventions

Blood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • Marie-Elise TRUCHETET, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Elise TRUCHETET, MD, PhD

CONTACT

05.56.79.55.56marie-elise.truchetet@chu-bordeaux.fr

Thomas BARNETCHE, PhD

CONTACT

05.57.82.04.93thomas.barnetche@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 11, 2020

Study Start

June 8, 2020

Primary Completion (Estimated)

June 1, 2034

Study Completion (Estimated)

June 1, 2034

Last Updated

September 4, 2025

Record last verified: 2025-09

Locations

FR(1)