NCT03575156

Brief Summary

Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 7, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

June 7, 2018

Last Update Submit

March 7, 2023

Conditions

Systemic Lupus ErythematosusSystemic Scleroderma

Keywords

Systemic Lupus ErythematosusSystemic Sclerodermaautoimmunitymicroparticlesplatelets

Outcome Measures

Primary Outcomes (1)

  • Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients

    At baseline (Day 0) and 12 months from baseline

Secondary Outcomes (4)

  • Disease activity scores for SLE patients

    At baseline (Day 0) and 12 months from baseline

  • Disease activity scores for SSc patients

    At baseline (Day 0) and 12 months from baseline

  • Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients

    At baseline (Day 0) and 12 months from baseline

  • Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc

    At baseline (Day 0) and 12 months from baseline

Study Arms (2)

Systemic lupus erythematosus (SLE)

EXPERIMENTAL
Biological: blood sampleBiological: urine sample

systemic scleroderma (SSc)

EXPERIMENTAL
Biological: blood sampleBiological: urine sample

Interventions

blood sampleBIOLOGICAL

36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Systemic lupus erythematosus (SLE)systemic scleroderma (SSc)
urine sampleBIOLOGICAL

6 ml

Systemic lupus erythematosus (SLE)systemic scleroderma (SSc)

Eligibility Criteria

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

You may qualify if:

  • diagnosis of systemic lupus erythematosus or systemic sclerosis;
  • age ≥ 18 years;
  • being affiliated to health insurance, willing to participate and to sign informed consent.

You may not qualify if:

  • pregnant or breastfeeding women;
  • patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicScleroderma, SystemicAutoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christophe RICHEZ, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 2, 2018

Study Start

September 20, 2018

Primary Completion

September 14, 2021

Study Completion

September 14, 2021

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)