Juvenile Systemic SclerosisJSScNCT06019234
Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
An observational study of Juvenile Systemic Sclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics. The incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Juvenile Systemic Sclerosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2023to 3 Oct 2024
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor subject (<18 years old) having a systemic sclerosis between 01/01/2012 and 30/06/2022.
Who may be able to join
- Minor subject (<18 years old)
- Diagnosis of systemic sclerosis between 01/01/2012 and 30/06/2022.
- Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.
Who cannot join
- Subject (or his parents) having expressed his (their) opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Ariane ZALOSZYC, MD, 33 3 88 12 77 49, ariane.zaloszyc@chru-strasbourg.fr
Rouba BECHARA, MD, 33 3 88 12 77 49, Rouba.bechara@chru-strasbourg.fr
About this study
Official title: Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics.
The incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic level.
Read more
The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution of connectivity does not seem quite identical to the evolution of adult scleroderma, adaptation of treatments seems judicious. However, data on the evolution under therapy in children are still poor.
Complications related to the pathology, iatrogeny and diagnostic delay are the first causes of mortality from this pathology and deserve to be studied and if possible avoided.
The main hypothesis of the research being to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.
- Conditions
- Juvenile Systemic Sclerosis
- Keywords
- Systemic Sclerosis, Juvenile Systemic Sclerosis, Immunosuppressive treatments
- Medical subject headings
- Juvenile systemic scleroderma, Scleroderma, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
The therapeutic response was evaluated by the EULAR DAS 28 -CRP
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start3 Mar 2023
- Primary completion3 Oct 2024 (estimated)
- Study completion3 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane ZALOSZYC, MD, Study director, University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019234
- Sponsor's protocol ID
- 9028
- Acronym
- JSSc
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort
- ClinicalTrials.gov ID
- NCT06019234
- Acronym / sponsor ID
- JSSc / 9028
- Conditions
- Juvenile Systemic Sclerosis
- Keywords
- Systemic Sclerosis, Juvenile Systemic Sclerosis, Immunosuppressive treatments
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 3 Oct 2024 (estimated)
- Study completion
- 3 Oct 2024 (estimated)
- First posted
- 31 Aug 2023 (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.
Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics.
The incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic level.
The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution of connectivity does not seem quite identical to the evolution of adult scleroderma, adaptation of treatments seems judicious. However, data on the evolution under therapy in children are still poor.
Complications related to the pathology, iatrogeny and diagnostic delay are the first causes of mortality from this pathology and deserve to be studied and if possible avoided.
The main hypothesis of the research being to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor subject (<18 years old) having a systemic sclerosis between 01/01/2012 and 30/06/2022.
Key inclusion criteria (3 listed)
- Minor subject (<18 years old)
- Diagnosis of systemic sclerosis between 01/01/2012 and 30/06/2022.
- Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.
Key exclusion criteria (1 listed)
- Subject (or his parents) having expressed his (their) opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The therapeutic response was evaluated by the EULAR DAS 28 -CRP
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
Ariane ZALOSZYC, MD study director
University Hospitals of Strasbourg
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 Juvenile Systemic Sclerosis, run by University Hospital, Strasbourg, France 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane ZALOSZYC, MD (33 3 88 12 77 42, ariane.zaloszyc@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The therapeutic response was evaluated by the EULAR DAS 28 -CRP (time frame: at 6 months). 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 2 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.