SclerodermaLoSQINCT07908108
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
An observational study of Scleroderma, run by Istituto Giannina Gaslini at 33 sites in 19 countries.
Trial summary
This international study adapts and validates the Localised Scleroderma Quality of Life Instrument (LoSQI) for children with JLS, a rare condition causing hardened skin and tissue. Goals \& Methods: Workstream 1: Translates and culturally adapts LoSQI for multi-national use, pre-testing it with patients and families. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Scleroderma
- How many people
- 272 participants
- Where
- 33 sitesin 19 countries
- Study dates
- 18 May 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children and young people with juvenile localised scleroderma
Who may be able to join
- Age 8-18 years with JLS diagnosed by a paediatric rheumatologist
- Understanding of written native language to level of 8 years old child
- Willing to consent/assent to the study
- Parent willing to consent in those under 16 years of age.
Who cannot join
- Any co-morbidity not related to JLS or its complications which may impact on PRO.
Trial locations and contacts
33 sites in 19 countries.
33 sites in 19 countries
Brazil4 sites
Hospital das Clínicas - Botucatu Medicine University, UNESP
Botucatu
Faculdade de Ciencias Medicas da UNICAMP
Campinas
University Hospital Pedro Ernesto
Rio de Janeiro
Universidade Federal de São Paulo
São Paulo
Italy4 sites
Azienda Ospedaliero Universitaria Meyer
Florence
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
Milan
Ospedale Pediatrico Bambino Gesu'
Roma
Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
Udine
United Kingdom4 sites
Alder Hey Children's NHS Foundation Trust
Liverpool
Royal Manchester Children's Hospital
Manchester
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne
Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust
Nottingham
Norway3 sites
Oslo University Hospital and University of Oslo
Oslo
University Hospital of Northern Norway
Tromsø
St. Olavs University Hospital of Trondheim
Trondheim
Turkey (Türkiye)3 sites
Health Sciences University, Umraniye Education and Research Hospital
Istanbul
Istanbul University Faculty of Medicine
Istanbul
Istanbul University, Cerrahpasa Medical Faculty
Istanbul
Netherlands2 sites
Emma Children Hospital, Academic Medical Center (AMC)
Amsterdam
Amalia Children's Hospital, Radboud University Medical Center
Nijmegen
China1 site
Children's hospital of Zhejiang University School of Medicine
Hangzhou
Croatia1 site
University Hospital Centre Zagreb, University School of Medicine
Zagreb
Germany1 site
Hamburg Centre for Pediatric and Adolescent Rheumatology
Hamburg
Greece1 site
University of Athens Medical School, Children Hospital Aghia Sophia
Athens
About this study
Official title: Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS): a Multicentre Study of the PRES Scleroderma Working Party in Collaboration With Members of the CARRA Scleroderma Working Group
This international study adapts and validates the Localised Scleroderma Quality of Life Instrument (LoSQI) for children with JLS, a rare condition causing hardened skin and tissue.
Goals \& Methods:
Workstream 1: Translates and culturally adapts LoSQI for multi-national use, pre-testing it with patients and families.
Workstream 2: Validates the tool through a prospective study of at least 100 patients across global centers (PRINTO, CARRA, PRES).
Impact: It creates the first multi-national, disease-specific Patient-Reported Outcome (PRO) for JLS, helping researchers combine global data and embedding quality-of-life tracking into routine clinical care.
- Conditions
- Scleroderma
- Keywords
- Cross-cultural adaptation and validation, Quality of Life
- Medical subject headings
- Scleroderma, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation
Successful cross-cultural adaptation of LoSQI for use in clinical/research setting
Measured: baseline and 4 months (+/- 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start18 May 2022
- Primary completion5 Feb 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Rheumatology European Society (PReS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908108
- Sponsor's protocol ID
- LoSQI - 11895
- Acronym
- LoSQI
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS): a Multicentre Study of the PRES Scleroderma Working Party in Collaboration With Members of the CARRA Scleroderma Working Group
- ClinicalTrials.gov ID
- NCT07908108
- Acronym / sponsor ID
- LoSQI / LoSQI - 11895
- Conditions
- Scleroderma
- Keywords
- Cross-cultural adaptation and validation, Quality of Life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Collaborators
- Pediatric Rheumatology European Society (PReS)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2026 (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.
This international study adapts and validates the Localised Scleroderma Quality of Life Instrument (LoSQI) for children with JLS, a rare condition causing hardened skin and tissue.
Goals \& Methods:
Workstream 1: Translates and culturally adapts LoSQI for multi-national use, pre-testing it with patients and families.
Workstream 2: Validates the tool through a prospective study of at least 100 patients across global centers (PRINTO, CARRA, PRES).
Impact: It creates the first multi-national, disease-specific Patient-Reported Outcome (PRO) for JLS, helping researchers combine global data and embedding quality-of-life tracking into routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children and young people with juvenile localised scleroderma
Key inclusion criteria (4 listed)
- Age 8-18 years with JLS diagnosed by a paediatric rheumatologist
- Understanding of written native language to level of 8 years old child
- Willing to consent/assent to the study
- Parent willing to consent in those under 16 years of age.
Key exclusion criteria (1 listed)
- Any co-morbidity not related to JLS or its complications which may impact on PRO.
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
Adaptation
Time frame: baseline and 4 months (+/- 2 months)
Successful cross-cultural adaptation of LoSQI for use in clinical/research setting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, run by Istituto Giannina Gaslini at 33 sites in 19 countries.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Brazil, Italy, United Kingdom, Norway, Turkey (Türkiye) and 14 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adaptation (time frame: baseline and 4 months (+/- 2 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 30 Oct 2026.