Prevalence of Hyperprolactinemia in Systemic Scleroderma

Scleroderma Clinical Trial

— SCLERO-PRL  

Official title:

Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746313
• Other study ID #: 2020_18
• Secondary ID: 2020-A03066-33
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: David Launay, MD,PhD
• Phone: 0320445962
• Email: david.launay[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperprolactinemia
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• Sclerosis
• Sclerosis, Systemic

Intervention

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

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Association pour la Formation et la Recherche en Médecine Interne (AFORMI)

Country where clinical trial is conducted

France, 

Outcome

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