Scleroderma (Limited and Diffuse)SCLEROMICSNCT02298777
Metabolomic Analysis of Systemic Sclerosis
An observational study of Scleroderma (Limited and Diffuse) and Undifferentiated Connective Tissue Disease, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years. The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease, Raynaud Disease
- What is being tested?
- - Skin biopsy - Urine sample - Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2014to 24 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with systemic sclerosis (SSc),
Who may be able to join
- Group 1 (scleroderma) : Patients with ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001)
- Group 2 (UCDT) : Patients with criteria proposed by Mosca et al. (1998)
- Group 3 (Raynaud) : Patients with primary and isolated Raynaud disease
- Group 4 (vascular disease) : Patients with type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke
- Group 5 (healthy control) : healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease)
Who cannot join
- Group 1 (scleroderma) : Patients not fulfilling ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001), or with another auto-immune disease
- Group 2 (UCDT) : Patients not fulfilling criteria proposed by Mosca et al. (1998)
- Group 3 (Raynaud) : Patients with no Raynaud disease
- Group 4 (vascular disease) : Patients with no vascular disease
- Group 5 (healthy control) : Patients with sign of connective tissue disease, Raynaud, or vascular disease)
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU
Dijon, 21079
Hôpitaux privés de Metz
Metz, 57045
CHU
Reims, 51092
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
About this study
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.
The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years).
Read more
Secondary purposes:
- Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs
- Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls
- Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients
- Conditions
- Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease, Raynaud Disease, Vascular Disease, Healthy Control Subjects
- Being tested
- - Skin biopsy - Urine sample - Blood sample
- Medical subject headings
- Scleroderma, Diffuse, Undifferentiated Connective Tissue Diseases, Raynaud Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Skin biopsy - Urine sample - Blood sampleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Scleroderma (SSc) patients (beginners and established forms). | Patients with the ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001)
Biological samples (skin, urine and blood):
* 1st point at patient's inclusion visit
* 2nd point (optional) at SSc patient's visceral complication (assessed during 3 years) Receives: Procedure: - Skin biopsy - Urine sample - Blood sample | |
| Undifferentiated Connective Tissue Disease (UCDT) patients | Patients with criteria proposed by Mosca et al. (1998)
Biological samples (skin, urine and blood):
- 1single point at patient's inclusion visit Receives: Procedure: - Skin biopsy - Urine sample - Blood sample | |
| Raynaud disease patients | Patients with primary and isolated Raynaud disease
Biological samples (skin, urine and blood):
- 1single point at patient's inclusion visit Receives: Procedure: - Skin biopsy - Urine sample - Blood sample | |
| Vascular disease patients | Patients with vascular disease (type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke)
Biological samples (skin, urine and blood):
- 1single point at patient's inclusion visit Receives: Procedure: - Skin biopsy - Urine sample - Blood sample | |
| Healthy control subjects | Healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease)
Biological samples (skin, urine and blood):
- 1single point at patient's inclusion visit Receives: Procedure: - Skin biopsy - Urine sample - Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
Metabolomic profiles will be classified in a database and compared.
Measured: 1 point at patient's inclusion visit
Secondary outcomes (1)
Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc.
Metabolomic profiles will be classified in a database and compared between each other's (SSc, UCDT, RD, VD and healthy control arms) We will look for a correlation between these profiles and the evolution of clinical and biological characteristics of SSc (SSc arm)
Measured: 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma (Limited and Diffuse)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chatelus Emmanuel, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298777
- Sponsor's protocol ID
- 5723
- Acronym
- SCLEROMICS
- Status last verified
- Aug 2025
- First submitted
- 6 Nov 2014
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Analysis of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT02298777
- Acronym / sponsor ID
- SCLEROMICS / 5723
- Conditions
- Scleroderma (Limited and Diffuse), Undifferentiated Connective Tissue Disease, Raynaud Disease, Vascular Disease, Healthy Control Subjects
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.
The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years).
Secondary purposes:
- Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs
- Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls
- Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Scleroderma (SSc) patients (beginners and established forms). | – | Procedure: - Skin biopsy - Urine sample - Blood samplePatients with the ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001) Biological samples (skin, urine and blood): * 1st point at patient's inclusion visit * 2nd point (optional) at SSc patient's visceral complication (assessed during 3 years) |
| Undifferentiated Connective Tissue Disease (UCDT) patients | – | Procedure: - Skin biopsy - Urine sample - Blood samplePatients with criteria proposed by Mosca et al. (1998) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit |
| Raynaud disease patients | – | Procedure: - Skin biopsy - Urine sample - Blood samplePatients with primary and isolated Raynaud disease Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit |
| Vascular disease patients | – | Procedure: - Skin biopsy - Urine sample - Blood samplePatients with vascular disease (type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit |
| Healthy control subjects | – | Procedure: - Skin biopsy - Urine sample - Blood sampleHealthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease) Biological samples (skin, urine and blood): - 1single point at patient's inclusion visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic sclerosis (SSc),
Key inclusion criteria (5 listed)
- Group 1 (scleroderma) : Patients with ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001)
- Group 2 (UCDT) : Patients with criteria proposed by Mosca et al. (1998)
- Group 3 (Raynaud) : Patients with primary and isolated Raynaud disease
- Group 4 (vascular disease) : Patients with type 2 diabetes, occlusive vascular disease, history of myocardial infarction or ischemic stroke
- Group 5 (healthy control) : healthy subjects (no sign of connective tissue disease, no Raynaud, no vascular disease)
Key exclusion criteria (5 listed)
- Group 1 (scleroderma) : Patients not fulfilling ACR / EULAR (2012) and / or criteria of Leroy and Medsger (2001), or with another auto-immune disease
- Group 2 (UCDT) : Patients not fulfilling criteria proposed by Mosca et al. (1998)
- Group 3 (Raynaud) : Patients with no Raynaud disease
- Group 4 (vascular disease) : Patients with no vascular disease
- Group 5 (healthy control) : Patients with sign of connective tissue disease, Raynaud, or vascular disease)
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 |
|---|---|---|
| - Skin biopsy - Urine sample - Blood sample | Procedure or surgery | Healthy control subjects, Raynaud disease patients, Scleroderma (SSc) patients (beginners and established forms)., Undifferentiated Connective Tissue Disease (UCDT) patients, Vascular disease patients |
Primary outcome
change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
Time frame: 1 point at patient's inclusion visit
Metabolomic profiles will be classified in a database and compared.
1 secondary outcome
Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc.
Time frame: 1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 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. This study is not recruiting at the moment.
Chatelus Emmanuel, MD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma (Limited and Diffuse) and Undifferentiated Connective Tissue Disease, run by University Hospital, Strasbourg, France at 4 sites 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early. Results are not available in the source record.
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?
change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion. (time frame: 1 point at patient's inclusion visit). 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 8 Aug 2025.