Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

Systemic Sclerosis Clinical Trial

— SCLERO-BIOBANK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04986514
• Other study ID #: 2020_58
• Secondary ID: 2021-A00107-34
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: April 2043

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: David Launay, MD,PhD
• Phone: 0320445962
• Email: david.launay[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 2043
• Est. primary completion date: April 2043
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EUSTAR score	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
Secondary	Medsger score	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