SCLERO-PRL: Prevalence of Hyperprolactinemia in Systemic Scleroderma

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04746313

Collaborator

Association pour la Formation et la Recherche en Médecine Interne (AFORMI) (Other)

200

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sclerosis, Systemic Scleroderma Hyperprolactinemia	Biological: blood test

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

the prevalence of hyperprolactinemia in scleroderma patients [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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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