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 M├ędecine Interne (AFORMI) (Other)
200
1
24
8.3

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
  • 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex [At 2 years]

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

  3. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hop Claude Huriez Chu Lille Lille France 59037

Sponsors and Collaborators

  • University Hospital, Lille
  • Association pour la Formation et la Recherche en M├ędecine Interne (AFORMI)

Investigators

  • Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT04746313
Other Study ID Numbers:
  • 2020_18
  • 2020-A03066-33
First Posted:
Feb 9, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021