CompletedNCT04746313SCLERO-PRLUpdated Dec 23, 2025

Prevalence of Hyperprolactinemia in Systemic Scleroderma

An observational study in Sclerosis, Systemic, Scleroderma and Hyperprolactinemia, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 71
Ages: 18 Years and older
Sex: All

Study 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

Conditions studied

Sclerosis, Systemic
Scleroderma
Hyperprolactinemia

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Keywords

Systemic sclerosis
Scleroderma
Prolactin

In context

Scleroderma, Systemic

610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.

This study's enrollment of 71 is below the median of 100 across 145 observational studies indexed under Scleroderma, Systemic.

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Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Scleroderma patients are from scheduled hospitalization Department of Internal Medicine and Clinical Immunology, CHU Lille Healthy subjects are from the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex

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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

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 71 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

Patients with systemic sclerosis
The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization
Biological: blood test
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

Interventions

Biologicalblood 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

What researchers measure

Primary outcomes

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.
Time frame: At 2 years

Secondary outcomes

the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex
Time frame: At 2 years
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
association between prolactin levels and biological markers of the immune system in scleroderma patients
Time frame: At 2 years

Study locations

1 site

Hop Claude Huriez Chu Lille
Lille, 59037, France

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in May 2021, 2 months.

Of 59 non-industry observational studies under Scleroderma, Systemic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 80. This study's 2 months is below that.

Counting every sponsor, half of 61 studies reached it within 44 months; a quarter within 15 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 8, 2021
First posted: Feb 9, 2021
StartActual: Mar 1, 2021
Primary completionActual: May 12, 2021
CompletionActual: May 12, 2021
Last update: Dec 23, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04746313
Lead sponsor: University Hospital, Lille
Collaborators: Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
Responsible party: Sponsor
First posted: Feb 9, 2021
Start date: Mar 1, 2021
Primary completion: May 12, 2021
Completion: May 12, 2021
Last update: Dec 23, 2025

Study contacts

David Launay, MD,PhD

principal investigator · University Hospital, Lille

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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