SclerodermaSCLERESONCT04265144
Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre
A study testing Blood samples, Biopsy and Bronchoalveolar samples in people with Scleroderma and Systemic Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic Sclerosis
- What is being tested?
- Blood samples, Biopsy and Bronchoalveolar samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2020to Jun 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient over 18 years old
- Patient with systemic scleroderma according to the ACR/EULAR 2013 criteria, or with a " very early systemic sclerosis " defined by the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
- Person affiliated or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research)
Who cannot join
- Pregnant or breastfeeding woman
- Patient under guardianship, curatorship or any other legal protection regime
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - service de rhumatologie
Bordeaux
Marie-Elise TRUCHETET, MD, PhD, 05.56.79.55.56 ext. +33, marie-elise.truchetet@chu-bordeaux.fr
Thomas BARNETCHE, PhD, 05.57.82.04.93 ext. +33, thomas.barnetche@chu-bordeaux.fr
About this study
Official title: Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to conducting quality research on this disease remains the development of well-documented patient cohorts with reliable biological samples. The main objective of this cohort is to study the natural progression of SSc in a cohort of patients followed over 5 years.
Read the detailed description
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. Its prevalence and incidence are difficult to assess, however, in France, a population survey conducted in Seine-St-Denis calculated a prevalence of 161 cases per million inhabitants.
The pathophysiology of SSc, the exact etiology of which remains unknown, involves an interaction between genetic and environmental factors. Its evolution can impact the aesthetic, functional and even vital prognosis of the affected patient.Within the analysis of SSc pathophysiology, a " very early systemic sclerosis " form of disease has been defined according to the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
At present, no treatment to control this disease is available. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to research remains the development of well-documented patient cohorts with quality biological samples. The investigators had the opportunity to start a major work on this plan with the VISS study (Vasculopathy and Inflammation in Systemic Scleroderma study) in 2012 as part of a project promoted by the University Hospital of Bordeaux (NCT02562079). This project has paved the way for many local, national and international collaborations. It has made it possible to structure and federate various partners of the Bordeaux University Hospital around translational research on SSc.
The investigators wish to continue our research and collaborations by further strengthening our expertise in the collection of rare and valuable biological samples for this disease.
- Conditions
- Scleroderma, Systemic Sclerosis
- Being tested
- Blood samples, Biopsy, Bronchoalveolar samples
- Keywords
- Cohort study, systemic sclerosis, prognosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
62 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
BiopsyOther
Skin biopsies only for volunteers among patients
Bronchoalveolar samplesOther
50 ml of bronchoalveolar samples if pulmonary flare requires this type of exploration only for volunteers among patients
BiopsyOther
Digestives biopsies if requires this type of exploration in the standard of care only for volunteers among patients
| Study group | Role | What they receive |
|---|---|---|
| subjects SSc diagnosed | Experimental | Patient with systemic scleroderma according to the American College of Rheumatology (ACR) / EULAR 2013 criteria Receives: Biological: Blood samples; Other: Biopsy; Other: Bronchoalveolar samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the main clinical characteristics of scleroderma patients
Worsening of the SSc according to the onset of a renal crisis (according to arterial hypertension > 150/85 mm Hg ), a pulmonary arterial hypertension (identified with a right heart catheterization), or an interstitial lung disease (identified with a chest CT-scan).
Measured: At baseline (Day 0) and 60 months after baseline
Secondary outcomes (7)
Proportion of pulmonary arterial hypertension diagnosis in SSc patients
Measured: At baseline (Day 0) and 60 months after baseline
Proportion of interstitial lung disease diagnosis in SSc patients
Measured: At baseline (Day 0) and 60 months after baseline
Proportion of renal crisis diagnosis in SSc patients
Measured: At baseline (Day 0) and 60 months after baseline
Mean of Rodnan score for the evaluation of disease activity for SSc patients, with higher values mean higher disease activity.
(Min value: 0 - Max value: 51)
Measured: At baseline (Day 0) and 60 months after baseline
Mean of Diffusing capacity (DLCO) for the evaluation of disease activity for SSc patients
Measured: At baseline (Day 0) and 60 months after baseline
Mean of Forced vital capacity (FVC) for the evaluation of disease activity for SSc patients
Measured: At baseline (Day 0) and 60 months after baseline
Proportion of therapeutic strategies set up for SSc patients
Measured: At baseline (Day 0) and 60 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start8 Jun 2020
- Primary completionJun 2034 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Elise TRUCHETET, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265144
- Sponsor's protocol ID
- CHUBX 2019/42
- Acronym
- SCLERESO
- Status last verified
- Sep 2025
- First submitted
- 5 Feb 2020
- Last updated
- 4 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT04265144
- Acronym / sponsor ID
- SCLERESO / CHUBX 2019/42
- Conditions
- Scleroderma, Systemic Sclerosis
- Keywords
- Cohort study, systemic sclerosis, prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- Jun 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 11 Feb 2020 (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 a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to conducting quality research on this disease remains the development of well-documented patient cohorts with reliable biological samples. The main objective of this cohort is to study the natural progression of SSc in a cohort of patients followed over 5 years.
Detailed description
Systemic sclerosis (SSc) is a rare form of connective tissue disease characterized by vascular involvement and the intensity of fibrosis. Its prevalence and incidence are difficult to assess, however, in France, a population survey conducted in Seine-St-Denis calculated a prevalence of 161 cases per million inhabitants.
The pathophysiology of SSc, the exact etiology of which remains unknown, involves an interaction between genetic and environmental factors. Its evolution can impact the aesthetic, functional and even vital prognosis of the affected patient.Within the analysis of SSc pathophysiology, a " very early systemic sclerosis " form of disease has been defined according to the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
At present, no treatment to control this disease is available. The lack of available treatment is largely due to the very fragmented understanding of the pathophysiology of SSc. However, one of the keys to research remains the development of well-documented patient cohorts with quality biological samples. The investigators had the opportunity to start a major work on this plan with the VISS study (Vasculopathy and Inflammation in Systemic Scleroderma study) in 2012 as part of a project promoted by the University Hospital of Bordeaux (NCT02562079). This project has paved the way for many local, national and international collaborations. It has made it possible to structure and federate various partners of the Bordeaux University Hospital around translational research on SSc.
The investigators wish to continue our research and collaborations by further strengthening our expertise in the collection of rare and valuable biological samples for this disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects SSc diagnosed | Experimental | Biological: Blood samples, Other: Biopsy, Other: Bronchoalveolar samplesPatient with systemic scleroderma according to the American College of Rheumatology (ACR) / EULAR 2013 criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Patient with systemic scleroderma according to the ACR/EULAR 2013 criteria, or with a " very early systemic sclerosis " defined by the presence of Raynaud's phenomenon and auto-antibodies in blood sample (ACAN positivity (≥1/160) with anti-Scl70, anti-centromere or anti-ARNPolIII specificity).
- Person affiliated or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research)
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman
- Patient under guardianship, curatorship or any other legal protection regime
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 |
|---|---|---|
| Blood samples62 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Biological | subjects SSc diagnosed |
| BiopsySkin biopsies only for volunteers among patients | Other | subjects SSc diagnosed |
| Bronchoalveolar samples50 ml of bronchoalveolar samples if pulmonary flare requires this type of exploration only for volunteers among patients | Other | subjects SSc diagnosed |
| BiopsyDigestives biopsies if requires this type of exploration in the standard of care only for volunteers among patients | Other | subjects SSc diagnosed |
Primary outcome
Change of the main clinical characteristics of scleroderma patients
Time frame: At baseline (Day 0) and 60 months after baseline
Worsening of the SSc according to the onset of a renal crisis (according to arterial hypertension > 150/85 mm Hg ), a pulmonary arterial hypertension (identified with a right heart catheterization), or an interstitial lung disease (identified with a chest CT-scan).
7 secondary outcomes
Proportion of pulmonary arterial hypertension diagnosis in SSc patients
Time frame: At baseline (Day 0) and 60 months after baseline
Proportion of interstitial lung disease diagnosis in SSc patients
Time frame: At baseline (Day 0) and 60 months after baseline
Proportion of renal crisis diagnosis in SSc patients
Time frame: At baseline (Day 0) and 60 months after baseline
Mean of Rodnan score for the evaluation of disease activity for SSc patients, with higher values mean higher disease activity.
Time frame: At baseline (Day 0) and 60 months after baseline
Mean of Diffusing capacity (DLCO) for the evaluation of disease activity for SSc patients
Time frame: At baseline (Day 0) and 60 months after baseline
Mean of Forced vital capacity (FVC) for the evaluation of disease activity for SSc patients
Time frame: At baseline (Day 0) and 60 months after baseline
Proportion of therapeutic strategies set up for SSc patients
Time frame: At baseline (Day 0) and 60 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
Marie-Elise TRUCHETET, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples, Biopsy and Bronchoalveolar samples in people with Scleroderma and Systemic Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Elise TRUCHETET, MD, PhD (05.56.79.55.56 ext. +33, marie-elise.truchetet@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the main clinical characteristics of scleroderma patients (time frame: At baseline (Day 0) and 60 months after baseline). 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 Sep 2025.