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Prevalence of Hyperprolactinemia in Systemic Scleroderma (SCLERO-PRL)

U

University Hospital, Lille

Status

Completed

Conditions

Scleroderma
Sclerosis, Systemic
Hyperprolactinemia

Treatments

Biological: blood test

Study type

Observational

Funder types

Other

Identifiers

NCT04746313
2020-A03066-33 (Other Identifier)
2020_18

Details and patient eligibility

About

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

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

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

Trial design

71 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

David Launay, MD,PhD

Data sourced from clinicaltrials.gov

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