Prevalence of Hyperprolactinemia in Systemic Scleroderma

NCT04746313 | Completed

• 2 other identifiers: 2020_182020-A03066-33
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sclerosis, Systemic; Scleroderma; Hyperprolactinemia

Keywords

Systemic sclerosis; Scleroderma; Prolactin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Patients with systemic sclerosis

The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization

Biological: blood test

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

Interventions

blood test BIOLOGICAL

* 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; Patients with systemic sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Association pour la Formation et la Recherche en Médecine Interne (AFORMI): collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Hyperprolactinemia

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2021
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)