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Trial record 8 of 80 for:    scleroderma, systemic sclerosis AND Skin | Recruiting, Not yet recruiting, Available Studies

Metabolomic Analysis of Systemic Sclerosis (SCLEROMICS)

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ClinicalTrials.gov Identifier: NCT02298777
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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 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

Condition or disease Intervention/treatment
Scleroderma (Limited and Diffuse) Undifferentiated Connective Tissue Disease Raynaud Disease Vascular Disease Healthy Control Subjects Procedure: - Skin biopsy - Urine sample - Blood sample

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Metabolomic Analysis of Systemic Sclerosis
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Group/Cohort Intervention/treatment
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)
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

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

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

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

Procedure: - Skin biopsy - Urine sample - Blood sample



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with systemic sclerosis (SSc),
Criteria

Inclusion criteria:

  • 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)

Exclusion criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298777


Contacts
Contact: Chatelus Emmanuel, MD 03 88 12 81 15 ext 0033 emmanuel.chatelus@chru-strasbourg.fr
Contact: Kleinmann Jean-François 03 88 12 79 62 jean-francois.kleinmann@chru-strasbourg.fr

Locations
France
CHU Recruiting
Dijon, France, 21079
Contact: BONNOTTE Bernard       bernard.bonnote@chu-dijon.fr   
CHU Active, not recruiting
Nancy, France, 54511
CHU Recruiting
Reims, France, 51092
Contact: SALMON Jean-Hughes, MD       jhsalmon@chu-reims.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Chatelus Emmanuel, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02298777     History of Changes
Other Study ID Numbers: 5723
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Sclerosis
Vascular Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Raynaud Disease
Pathologic Processes
Cardiovascular Diseases
Skin Diseases
Peripheral Vascular Diseases