Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

NCT ID: NCT04986514

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2043-04-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with systemic sclerosis

Bio-banking without genetic analysis

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Launay, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

David Launay, MD,PhD

Role: CONTACT

david.launay@chru-lille.fr

0320445962 ext. +33

Other Identifiers

2021-A00107-34

Identifier Type: OTHER

Identifier Source: secondary_id

2020_58

Identifier Type: -

Identifier Source: org_study_id