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OpenTrials
Completed

NCT Number: NCT04746313

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

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Key information

Conditions

Sclerosis, Systemic Brain Diseases Central Nervous System Diseases Connective Tissue Diseases Endocrine System Diseases Hyperpituitarism Hyperprolactinemia Hypothalamic Diseases Nervous System Diseases Pituitary Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. the prevalence of hyperprolactinemia in scleroderma patients

    Time frame: 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

  1. the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex

    Time frame: At 2 years

  2. the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis

    Time frame: At 2 years

  3. association between prolactin levels and biological markers of the immune system in scleroderma patients

    Time frame: At 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study title

Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

Acronym: SCLERO-PRL

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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