Prevalence of Hyperprolactinemia in Systemic Scleroderma

NCT04746313 — Completed, 71 participants, University Hospital, Lille

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

Registry	NCT04746313, acronym SCLERO-PRL
Status	Completed
Study type	Observational
Enrollment	71 (Actual)
Sponsor	University Hospital, Lille (Other); collaborators: Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
Conditions	Sclerosis, Systemic, Scleroderma, Hyperprolactinemia
Interventions	blood test (Biological)
Dates	start 2021-03-01, primary completion 2021-05-12, completion 2021-05-12, first posted 2021-02-09, last updated 2025-12-23
Locations	1 site in France

-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

Expand all sections · Collapse all

+Arms and interventions

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

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

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Hop Claude Huriez Chu Lille	Lille	France

+Investigators

David Launay, MD,PhD, Principal investigator, University Hospital, Lille

My Notes

Public

To Read Reading Read