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Prevalence of Hyperprolactinemia in Systemic Scleroderma

NCT ID: NCT04746313

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-05-12

Brief Summary

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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

Detailed Description

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Conditions

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Sclerosis, Systemic Scleroderma Hyperprolactinemia

Keywords

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Systemic sclerosis Scleroderma Prolactin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with systemic sclerosis

The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization

blood test

Intervention Type 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

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

blood test

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Launay, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A03066-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020_18

Identifier Type: -

Identifier Source: org_study_id