Sclerosis, SystemicSCLERO-PRLNCT04746313
Prevalence of Hyperprolactinemia in Systemic Scleroderma
An observational study of Sclerosis, Systemic and Scleroderma, run by University Hospital, Lille at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sclerosis, Systemic, Scleroderma, Hyperprolactinemia
- What is being tested?
- blood test
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 12 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the 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
- Conditions
- Sclerosis, Systemic, Scleroderma, Hyperprolactinemia
- Being tested
- blood test
- Keywords
- Systemic sclerosis, Scleroderma, Prolactin
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testBiological
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with systemic sclerosis | The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization Receives: 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 Receives: Biological: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 years
Secondary outcomes (3)
the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex
Measured: At 2 years
the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis
Measured: At 2 years
association between prolactin levels and biological markers of the immune system in scleroderma patients
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746313
- Sponsor's protocol ID
- 2020_18
- Other IDs
- 2020-A03066-33
- Acronym
- SCLERO-PRL
- Status last verified
- Dec 2025
- First submitted
- 8 Feb 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT04746313
- Acronym / sponsor ID
- SCLERO-PRL / 2020_18
- Conditions
- Sclerosis, Systemic, Scleroderma, Hyperprolactinemia
- Keywords
- Systemic sclerosis, Scleroderma, Prolactin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with systemic sclerosis | – | Biological: blood testThe study will be systematically offered to any scleroderma patient seen in scheduled hospitalization |
| Healthy subjects | – | Biological: blood testHealthy subjects who will donate blood to the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- man or woman over 18 years old
- with systemic sclerosis meeting ACR-EULAR 2013 criteria
- having given his no opposition
- being social insured
- man or woman over 18 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Healthy subjects, Patients with systemic sclerosis |
Primary outcome
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.
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Launay, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sclerosis, Systemic and Scleroderma, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of hyperprolactinemia in scleroderma patients (time frame: At 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.