Clinical trial NCT04986514: Implementation of a Biological Sample Collection in Systemic Sclerosis Patients
Official title: Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Systemic Sclerosis
Keywords: Systemic sclerosis
Biomarkers
Bio-banking
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital

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.


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

Primary outcomes:
measure: Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage
timeFrame: Through study completion an average of 10 years
Secondary outcomes:
measure: EUSTAR score
timeFrame: Baseline and through study completion, an average of 10 years
measure: Medsger score
timeFrame: Baseline and through study completion, an average of 10 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: