Prevalence of Hyperprolactinemia in Systemic Scleroderma (SCLERO-PRL)

Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

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

Study Overview

• Status: Recruiting
• Conditions: Scleroderma; Hyperprolactinemia; Sclerosis, Systemic
• Intervention / Treatment: Biological: blood test

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: David Launay, MD,PhD; Phone Number: +33 0320445962; Email: david.launay@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Claude Huriez Chu Lille
    • Principal Investigator: David Launay, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Scleroderma patients are from scheduled hospitalization Department of Internal Medicine and Clinical Immunology, CHU Lille Healthy subjects are from the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with systemic sclerosis; The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the prevalence of hyperprolactinemia in scleroderma patients	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.	At 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
• Investigators: Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Scleroderma; Systemic sclerosis; Prolactin
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Endocrine System Diseases; Connective Tissue Diseases; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Hyperprolactinemia
• Other Study ID Numbers: 2020_18; 2020-A03066-33 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No