NCT04986514Withdrawn
Implementation of a Biological Sample Collection in Systemic Sclerosis Patients
Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients
Source: ClinicalTrials.gov · Last updated 4 May 2026
Reason given: withdrawed by the sponsor. A concurrent study is currently underway in the department
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Observational
- Enrollment
- 0 (actual)
- First submitted
- 22 Jul 2021
- Start date
- Apr 2023
- Primary completion date
- Apr 2043
- Lead sponsor
- University Hospital, Lille
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04986514
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.