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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03508375
Acronym
SCLEROLUNG
Enrollment
75
Registered
2018-04-25
Start date
2018-05-15
Completion date
2021-11-30
Last updated
2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Scleroderma

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.

Interventions

BIOLOGICALblood samples

blood samples

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
fractalkine levels24 months

Countries

France

Contacts

Primary ContactAudrey BENYAMINE, MD
audrey.benyamine@ap-hm.fr+33 491386036
Backup Contactalexandra giuliani
drci@ap-hm.fr0491382747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026