Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03508375
Other study ID # 2018-03
Secondary ID 2018-A00066-49
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2018
Est. completion date November 2021

Study information

Verified date June 2019
Source Assistance Publique Hopitaux De Marseille
Contact Audrey BENYAMINE, MD
Phone +33 491386036
Email audrey.benyamine@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date November 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
blood samples
blood samples

Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille BDR

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary fractalkine levels 24 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03629002 - BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA
Terminated NCT00377455 - Placebo Controlled Trial of Bosentan in Scleroderma Patients Phase 2
Completed NCT00278525 - Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma Phase 2
Completed NCT00318188 - Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis N/A
Completed NCT03575156 - Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis N/A
Active, not recruiting NCT01413100 - Scleroderma Treatment With Autologous Transplant (STAT) Study Phase 2
Completed NCT00622895 - Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03816189 - Role of Eosinophil in Fibrogenesis of Systemic Sclerosis
Completed NCT01295736 - Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY Phase 3
Completed NCT02213705 - Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells Phase 1/Phase 2
Active, not recruiting NCT01309997 - Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease Phase 2
Completed NCT00697736 - Cardiac Repercussion of Systemic Sclerodermias N/A
Completed NCT02349009 - Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial Phase 1/Phase 2
Completed NCT00318175 - Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis Phase 2
Completed NCT03262922 - Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment
Recruiting NCT03816345 - Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer Phase 1
Recruiting NCT04380831 - TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis Early Phase 1
Terminated NCT00628797 - Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis Phase 1/Phase 2
Recruiting NCT05672992 - Longitudinal Spatial Frequency Domain Imaging Study N/A
Recruiting NCT05726630 - Clinical Study of Divozilimab in Patients With Systemic Scleroderma Phase 3