Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

NCT04986514 | Withdrawn

• 2 other identifiers: 2020_582021-A00107-34
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis; Biomarkers; Bio-banking

Outcome Measures

Primary Outcomes (1)

• Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage

  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 Outcomes (2)

• EUSTAR score

  Baseline and through study completion, an average of 10 years

• Medsger score

  Baseline and through study completion, an average of 10 years

Study Arms (1)

Patients with systemic sclerosis

Other: Bio-banking without genetic analysis

Interventions

Bio-banking without genetic analysis OTHER

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.

Patients with systemic sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum (3 aliquots) and plasma (3 aliquots)

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 3, 2021
• Study Start: April 1, 2023
• Primary Completion (Estimated): April 1, 2043
• Study Completion (Estimated): April 1, 2043
• Last Updated: May 4, 2026

Record last verified: 2026-04