Systemic SclerosisSCLEROBRESTNCT05532865
Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking
An observational study of Systemic Sclerosis, run by University Hospital, Brest at 1 site in France.
Trial summary
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis. It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota… 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?
- Blood samples, Stool samples and Skin swab samples
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 13 Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Major patient with systemic sclerosis defined according to the EULAR 2013 criteria
Who may be able to join
- Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
- Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
- Patient affiliated to the social security system
- Patient having signed a written informed consent.
Who cannot join
- Minor
- Patient under legal protection (guardianship, curatorship)
- Refusal to participate
- Patient unable to consent
- Pregnant or breastfeeding woman
- Hemoglobin (Hb) level < 7g/dl
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
CHRU de Brest
Brest, 29200
CLAIRE DE MOREUIL, 0033298145303, claire.demoreuil@chu-brest.fr
BENEDICTE ROUVIERE, 0033298347345, benedicte.rouviere@chu-brest.fr
About this study
Official title: Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.
It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.
- Conditions
- Systemic Sclerosis
- Being tested
- Blood samples, Stool samples, Skin swab samples, Questionnaires on quality of life, pain and disability, Skin biopsies
- Keywords
- Systemic Sclerosis, Patient library
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
80 ml of blood samples collected at inclusion and at 18 months
Stool samplesOther
A stool sample for collection of digestive microbiota at inclusion
Skin swab samplesOther
A skin swab sample for collection of skin microbiota at inclusion and at 18 months
Questionnaires on quality of life, pain and disabilityOther
At inclusion and each year for 5 years
Skin biopsiesOther
At inclusion and 18 months
| Study group | Role | What they receive |
|---|---|---|
| Adults with systemic sclerosis | It is a descriptive cohort of systemic sclerosis patients Receives: Other: Blood samples; Other: Stool samples; Other: Skin swab samples; Other: Questionnaires on quality of life, pain and disability; Other: Skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
To assess whether age correlates with disease profile and progression
Measured: 5 years
Sex
To assess whether sex correlates with disease profile and progression
Measured: 5 years
Weight
To assess whether weight correlates with disease profile and progression
Measured: 5 years
Medical history
To assess whether medical history predicts the pattern and course of the disease
Measured: 5 years
Family history
To assess whether family history predicts the pattern and course of the disease
Measured: 5 years
Rodnan score
This score evaluates the thickness of the skin from 0 to 51. 0 meaning the absence of scleroderma (the healthiest score) and 51 completely sclerotic skin (the worst possible score)
Measured: 5 years
active digital ulcers
4 characteristics must be taken into account:
- the type of ulcer: mechanical/on calcinosis/ischemic
- the recent/semi-recent/chronic character,
- the painful character or not,
- the total number of fingers affected on the 10 fingers.
Measured: 5 years
dyspnea
- stage I: absence of dyspnea for usual efforts: no discomfort is felt in everyday life,
- stage II: dyspnoea for usual heavy exertion, such as brisk or hill walking or climbing stairs (≥ 2 floors),
- stage III: dyspnea for low intensity efforts of everyday life, such as walking on flat ground or climbing stairs (< 2 floors),
- stage IV: permanent dyspnea at rest or for minimal effort (putting on a garment, for example)
Measured: 5 years
Free Carbon Monoxide Diffusion (DLCO)
Free Carbon Monoxide Diffusion (DLCO) in percentage.
Measured: 5 years
6-minute walk test
Distance (in meters) covered in the 6-minute walk test.
Measured: 5 years
systemic pulmonary arterial pressures
Measured on cardiac ultrasound.
Measured: 5 years
Secondary outcomes (3)
SF-36 (Short-Form 36)
The SF-36 is an indicator of health status and quality of life. The SF-36 has eight dimensions; the scores are weighted sums of the questions in each section. This scores range from 0 - 100. Lower scores indicate more disability and higher scores less disability.
The eight dimensions of this score are:
- Vitality
- Physical functioning
- Bodily pain
- General health perceptions
- Physical role functioning
- Emotional role functioning
- Social role functioning
- Mental health
Measured: 5 years
BPI : Pain scale
A quick and easy way to measure the intensity of pain and its impact on daily activities. Patients rate the maximum, minimum, average and current intensity of their pain and the influence of pain on seven aspects of functional ability. 3 scores are obtained between 0 and 10, with 10 corresponding to :
- the worst pain experienced in the last 24 hours
- the highest pain intensity combining the most intense, the least intense, the average pain and the pain experienced at the time of the questionnaire
- the highest interference of the pain on daily activities
Measured: 5 years
HAQ- Health Assessment Questionnaire - Disability Index
Evolution of HAQ-DI (Health Assessment Questionnaire - Disability Index) during follow-up 8 fields questionnaire (DRESSING \& GROOMING, ARISING, EATING, WALKING, HYGIENE, REACH, GRIP, Other activities), scaled from 0 to 3, 3 meaning a worse outcome
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start13 Oct 2022
- Primary completion13 Oct 2032 (estimated)
- Study completion13 Oct 2032 (estimated)
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.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532865
- Sponsor's protocol ID
- 29BRC21.0258
- Acronym
- SCLEROBREST
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank
- ClinicalTrials.gov ID
- NCT05532865
- Acronym / sponsor ID
- SCLEROBREST / 29BRC21.0258
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic Sclerosis, Patient library
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 13 Oct 2032 (estimated)
- Study completion
- 13 Oct 2032 (estimated)
- First posted
- 8 Sep 2022 (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.
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.
It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with systemic sclerosis | – | Other: Blood samples, Other: Stool samples, Other: Skin swab samples, Other: Questionnaires on quality of life, pain and disability, Other: Skin biopsiesIt is a descriptive cohort of systemic sclerosis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient with systemic sclerosis defined according to the EULAR 2013 criteria
Key inclusion criteria (4 listed)
- Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
- Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
- Patient affiliated to the social security system
- Patient having signed a written informed consent.
Key exclusion criteria (6 listed)
- Minor
- Patient under legal protection (guardianship, curatorship)
- Refusal to participate
- Patient unable to consent
- Pregnant or breastfeeding woman
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 samples80 ml of blood samples collected at inclusion and at 18 months | Other | Adults with systemic sclerosis |
| Stool samplesA stool sample for collection of digestive microbiota at inclusion | Other | Adults with systemic sclerosis |
| Skin swab samplesA skin swab sample for collection of skin microbiota at inclusion and at 18 months | Other | Adults with systemic sclerosis |
| Questionnaires on quality of life, pain and disabilityAt inclusion and each year for 5 years | Other | Adults with systemic sclerosis |
| Skin biopsiesAt inclusion and 18 months | Other | Adults with systemic sclerosis |
Primary outcome
Age
Time frame: 5 years
To assess whether age correlates with disease profile and progression
Sex
Time frame: 5 years
To assess whether sex correlates with disease profile and progression
Weight
Time frame: 5 years
To assess whether weight correlates with disease profile and progression
Medical history
Time frame: 5 years
To assess whether medical history predicts the pattern and course of the disease
Family history
Time frame: 5 years
To assess whether family history predicts the pattern and course of the disease
Rodnan score
Time frame: 5 years
This score evaluates the thickness of the skin from 0 to 51. 0 meaning the absence of scleroderma (the healthiest score) and 51 completely sclerotic skin (the worst possible score)
active digital ulcers
Time frame: 5 years
4 characteristics must be taken into account: 1. the type of ulcer: mechanical/on calcinosis/ischemic 2. the recent/semi-recent/chronic character, 3. the painful character or not, 4. the total number of fingers affected on the 10 fingers.
dyspnea
Time frame: 5 years
* stage I: absence of dyspnea for usual efforts: no discomfort is felt in everyday life, * stage II: dyspnoea for usual heavy exertion, such as brisk or hill walking or climbing stairs (≥ 2 floors), * stage III: dyspnea for low intensity efforts of everyday life, such as walking on flat ground or climbing stairs (< 2 floors), * stage IV: permanent dyspnea at rest or for minimal effort (putting on a garment, for example)
Free Carbon Monoxide Diffusion (DLCO)
Time frame: 5 years
Free Carbon Monoxide Diffusion (DLCO) in percentage.
6-minute walk test
Time frame: 5 years
Distance (in meters) covered in the 6-minute walk test.
systemic pulmonary arterial pressures
Time frame: 5 years
Measured on cardiac ultrasound.
3 secondary outcomes
SF-36 (Short-Form 36)
Time frame: 5 years
BPI : Pain scale
Time frame: 5 years
HAQ- Health Assessment Questionnaire - Disability Index
Time frame: 5 years
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University Hospital, Brest 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 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. 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 Claire DE MOREUIL (0033298145303, claire.demoreuil@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: 5 years). The study lists 11 primary outcomes in all. 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 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.