Systemic SclerosisSCLERO-BIOBANKNCT04986514
Implementation of a Biological Sample Collection in Systemic Sclerosis Patients
An observational study of Systemic Sclerosis, run by University Hospital, Lille.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Bio-banking without genetic analysis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2043
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients
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
- Being tested
- Bio-banking without genetic analysis
- Keywords
- Systemic sclerosis, Biomarkers, Bio-banking
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-banking without genetic analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with systemic sclerosis | Not described Receives: Other: Bio-banking without genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion an average of 10 years
Secondary outcomes (2)
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
Measured: Baseline and through study completion, an average of 10 years
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
Measured: Baseline and through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study startApr 2023 (estimated)
- Primary completionApr 2043 (estimated)
- Study completionApr 2043 (estimated)
Why it stopped: withdrawed by the sponsor. A concurrent study is currently underway in the department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986514
- Sponsor's protocol ID
- 2020_58
- Other IDs
- 2021-A00107-34
- Acronym
- SCLERO-BIOBANK
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients
- ClinicalTrials.gov ID
- NCT04986514
- Acronym / sponsor ID
- SCLERO-BIOBANK / 2020_58
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis, Biomarkers, Bio-banking
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: withdrawed by the sponsor. A concurrent study is currently underway in the department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2043 (estimated)
- Study completion
- Apr 2043 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with systemic sclerosis | – | Other: Bio-banking without genetic analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-banking without genetic analysisFor 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. | Other | Patients with systemic sclerosis |
Primary outcome
Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage
Time frame: Through study completion an average of 10 years
Identify biomarkers that are associated with disease prognosis and treatment response during 10 years of follow-up.
2 secondary outcomes
EUSTAR score
Time frame: Baseline and through study completion, an average of 10 years
Medsger score
Time frame: Baseline and through study completion, an average of 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Related trials for Systemic Sclerosis
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Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
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A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
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Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Launay, MD,PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage (time frame: Through study completion an average of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.