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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 : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date November 6, 2014
First Posted Date November 24, 2014
Last Update Posted Date August 20, 2019
Actual Study Start Date December 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02298777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 19, 2014)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Metabolomic Analysis of Systemic Sclerosis
Official Title Metabolomic Analysis of Systemic Sclerosis
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with systemic sclerosis (SSc),
Condition
  • Scleroderma (Limited and Diffuse)
  • Undifferentiated Connective Tissue Disease
  • Raynaud Disease
  • Vascular Disease
  • Healthy Control Subjects
Intervention Procedure: - Skin biopsy - Urine sample - Blood sample
Study Groups/Cohorts
  • 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)
    Intervention: 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

    Intervention: 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

    Intervention: 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

    Intervention: 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

    Intervention: Procedure: - Skin biopsy - Urine sample - Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 19, 2014)
140
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02298777
Other Study ID Numbers 5723
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators
Principal Investigator: Chatelus Emmanuel, MD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date August 2019