Prevalence of Hyperprolactinemia in Systemic Scleroderma

Overview

Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin

Full Title of Study: “Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2023

Interventions

  • Biological: blood test
    • to analysis prolactin in healthy subjects and scleroderma patients then to analysis in only scleroderma patients: thyroid-stimulating hormone (TSH), thyroxine (T4), luteinizing hormone (LH), oestradiol, follicle-stimulating hormone (FSH), BAFF (B-cell activating factor), IL-6 (interleukin 6) and endoglin

Arms, Groups and Cohorts

  • Patients with systemic sclerosis
    • The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization
  • Healthy subjects
    • Healthy subjects who will donate blood to the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex

Clinical Trial Outcome Measures

Primary Measures

  • the prevalence of hyperprolactinemia in scleroderma patients
    • Time Frame: At 2 years
    • Rate of prolactin measured by immuno-chemiluminescence (Abbott Architect automaton). The presence of a defined hyperprolactinemia at the University Hospital of Lille: for women, prolactin level higher than 26.5 ng/mL and for men, higher than 19.4 ng/mL.

Secondary Measures

  • the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex
    • Time Frame: At 2 years
  • the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis
    • Time Frame: At 2 years
  • association between prolactin levels and biological markers of the immune system in scleroderma patients
    • Time Frame: At 2 years

Participating in This Clinical Trial

Inclusion Criteria

Scleroderma patients:

  • man or woman over 18 years old – with systemic sclerosis meeting ACR-EULAR 2013 criteria – having given his no opposition – being social insured Healthy subjects: – man or woman over 18 years old – donation of blood to the EFS – matched on age (+/- 5 years) and sex – having given his no opposition Exclusion Criteria:

  • Man or woman under 18 years old – Pregnant or breastfeeding women – Receiving medical treatment inducing dysfunction of the hypothalamic pituitary axis – Refusing or unable to give no objection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Association pour la Formation et la Recherche en M├ędecine Interne (AFORMI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Launay, MD,PhD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • David Launay, MD,PhD, 0320445962, david.launay@chru-lille.fr

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