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Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis (SCLEROLUNG)

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ClinicalTrials.gov Identifier: NCT03508375
Recruitment Status : Unknown
Verified June 2019 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : April 25, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:

Systemic Scleroderma (SCS) is an autoimmune disease characterized by vascular involvement, a dysimmune condition, cutaneous and visceral fibrosis. Interstitial lung disease (ILD) affects 75% of SSc patients and is the leading cause of death in SSc. No diagnostic or prognostic biomarkers of SSc-associated ILD have been validated to date. The search for such a serum biomarker is essential to assess the severity of these patients and to help the therapeutic management.

We have shown that soluble fractalkine is elevated in SSc patients, especially in SSc patients with ILD. The fractalkine is both an endothelial adhesion molecule and a chemokine that binds to the CX3CR1 receptor expressed by immune populations. It would thus reflect the vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this disease.

Objectives and means: We aim to perform a low-risk interventional biomedical research which main objective is the quantitative evaluation of soluble fractalkine in SSc patients with ILD in comparison with SSc patients without ILD. This epidemiological, explanatory, analytical, single-center study will comprise three groups: 1 / SSc without ILD (control group in the context of SSc), 2/ SSc with ILD and 3/ patients with idiopathic pulmonary fibrosis (IPF) (control group of the ILD). Secondary objectives are evaluation of: 1 / fractalkine levels in the IPF, 2 / correlations between fractalkine levels and severity of ILD and of SSc disease over time, 3 / correlations between fractalkine and 2 other biomarkers: KL-6 (marker of pulmonary fibrosis) and soluble CD146 (sCD146, marker of vasculopathy), 4 / predictive values of the decline in lung function of these 3 markers.


Condition or disease Intervention/treatment Phase
Systemic Scleroderma Biological: blood samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SSc without ILD Biological: blood samples
blood samples
Experimental: SSc with ILD Biological: blood samples
blood samples
Active Comparator: patients with idiopathic pulmonary fibrosis Biological: blood samples
blood samples


Outcome Measures
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Primary Outcome Measures :
  1. fractalkine levels [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over the age of 18 with SSc with or without ILD with a medical follow up in AP-HM
  • Patients, followed at AP-HM, with IPF

Exclusion Criteria:

  • Impossibility of taking blood
  • Known diagnosis of respiratory disorders other than SSc-associated ILD and IPF
  • An infection in progress
  • An evolutive cancer
  • Chemotherapy or radiation therapy in progress
  • Minors
  • Pregnant or lactating women
  • Majors under guardianship
  • People staying in a health or social facility
  • People in emergency
  • Non-beneficiaries of a social security scheme
  • Persons deprived of their liberty
Contacts and Locations
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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): NCT03508375


Contacts
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Contact: Audrey BENYAMINE, MD +33 491386036 audrey.benyamine@ap-hm.fr
Contact: alexandra giuliani 0491382747 drci@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, BDR, France, 13354
Contact: ALEXANDRA GIULIANI, DRCI    0491382747    drci@ap-hm.fr   
Principal Investigator: audrey benyamine, md         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03508375    
Other Study ID Numbers: 2018-03
2018-A00066-49 ( Other Identifier: N°IDRCB )
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases
 Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases