Implementation of a Biological Sample Collection in Systemic Sclerosis Patients (SCLERO-BIOBANK)

April 28, 2026 updated by: University Hospital, Lille

Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients

Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital

Description

Inclusion Criteria:

  • Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
  • Fulfilling the ACR/EULAR and/or VEDOSS criteria for SSc
  • Being insured by the French social security system
  • Having the ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

  • Administrative reasons: unable to receive informed information, lack of social security coverage
  • Pregnant or lactating women
  • Persons deprived of liberty
  • Minors or protected adults
  • Persons who have refused or are unable to give informed consent
  • Persons in emergency situations

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with systemic sclerosis
Other: Bio-banking without genetic analysis
For patients included in SCLERO-BIOBANK study, 2 blood samples will be collected at each SSc evaluation (usually once a year), in addition to the routine care blood collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage
Time Frame: Through study completion an average of 10 years
Identify biomarkers that are associated with disease prognosis and treatment response during 10 years of follow-up.
Through study completion an average of 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EUSTAR score
Time Frame: Baseline and through study completion, an average of 10 years
Identify new biomarkers associated with disease severity and disease activity at study entry and the evolution of disease severity and activity over time
Baseline and through study completion, an average of 10 years
Medsger score
Time Frame: Baseline and through study completion, an average of 10 years
Identify new biomarkers associated with disease severity and disease activity at study entry and the evolution of disease severity and activity over time
Baseline and through study completion, an average of 10 years

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

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 (Estimated)

April 1, 2023

Primary Completion (Estimated)

April 1, 2043

Study Completion (Estimated)

April 1, 2043

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_58
  • 2021-A00107-34 (Other Identifier: ID-RCB number, ANSM)

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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