NCT03508375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

April 16, 2018

Last Update Submit

June 17, 2019

Conditions

Systemic Scleroderma

Outcome Measures

Primary Outcomes (1)

  • fractalkine levels

    24 months

Study Arms (3)

SSc without ILD

EXPERIMENTAL
Biological: blood samples

SSc with ILD

EXPERIMENTAL
Biological: blood samples

patients with idiopathic pulmonary fibrosis

ACTIVE COMPARATOR
Biological: blood samples

Interventions

blood samplesBIOLOGICAL

blood samples

SSc with ILDSSc without ILDpatients with idiopathic pulmonary fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, BDR, 13354, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • jean-olivier ARNAUD

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Central Study Contacts

Audrey BENYAMINE, MD

CONTACT

+33 491386036audrey.benyamine@ap-hm.fr

alexandra giuliani

CONTACT

0491382747drci@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

May 15, 2018

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

FR(1)