SclerodermaFRESS-VQNCT07888842
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
An observational study of Scleroderma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this study is to validate, in French, new questionnaires assessing disability, quality of life, and patient-reported outcomes in systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- Questionnaires
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of French-speaking patients with systemic sclerosis who meet the 2013 ACR/EULAR classification criteria. The objective of this study is to validate French-language disability questionnaires for this patient population.
Who may be able to join
- Patients aged 18 years or older with SSc who meet the 2013 ACR/EULAR criteria (Van Hoogen et al., ARD 2013).
- Patients with a good understanding of the French language.
- Who have provided informed consent to participate in the study
Who cannot join
- Patients with associated chronic disabling conditions: stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputees, etc.
- Patients with cognitive impairments
- Patients with difficulties understanding or speaking French
- Adults under legal guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Department of Internal Medicine - Cochin hospital
Paris, IDF, 75014
Benjamin CHAIGNE, MD, PhD, 00 33 1 58 41 22 15, benjamin.chaigne@aphp.fr
About this study
Official title: Validation of Questionnaires on Disability, Health, and Quality of Life and Patient Assessment in Systemic Sclerosis - French Systemic Sclerosis Validated Questionnaires
The main objective of this study is to validate, in French, new questionnaires assessing disability, quality of life, and patient-reported outcomes in systemic sclerosis.
Read the detailed description
Systemic sclerosis is a disease characterized by the development of fibrotic lesions in the skin and deep internal organs such as the lungs, heart, and gastrointestinal tract, as well as vascular manifestations such as Raynaud's phenomenon, and, more rarely, pulp ischemia, pulmonary arterial hypertension (PAH), or renal crisis.
Eligible patients are the 250 patients with SSc. They will receive by mail an information sheet/patient consent form (in duplicate) along with an explanatory letter and the M0 and M3 questionnaires for their review. They will then be contacted by phone to answer any questions they may have (particularly regarding the study's objectives and procedures). If they agree to participate, they will be asked to complete and sign both copies of the consent form, complete the "M0" questionnaires, and return one copy of the signed consent form and the "M0" questionnaires by mail using the pre-addressed envelope provided for this purpose or in person. Patients will then return the completed self-administered questionnaires to M3 by mail (or by email or in person, depending on the patient's preference).
More recently, new disability and patient assessment questionnaires have been introduced internationally: the ScleroID (Becker MO 2022) and the SSPRO (Man A et al. 2017). While these questionnaires are recognized as useful for ScleroID internationally, their development did not include validation in French within a French population. In fact, these questionnaires have not been translated into French and therefore cannot be used without French-language validation.
- Conditions
- Scleroderma
- Being tested
- Questionnaires
- Keywords
- Systemic Scleroderma
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
French-language questionnaires assessing disability, quality of life, and disease status.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF 17 (Cochin 17-item Scleroderma Functional scale)
Questionnaire developed by the internal medicine department's research group for the SCISCIF studies to assess the patient's self-perceived health.
The aim of this study is to validate French-language disability questionnaires for this patient population.
Measured: Day 0
CSF 17 (Cochin 17-item Scleroderma Functional scale)
Questionnaire developed by the internal medicine department's research group for the SCISCIF studies to assess the patient's self-perceived health.
The aim of this study is to validate French-language disability questionnaires for this patient population.
Measured: Month 3
ScleroID questionnaire
Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
Measured: Day 0
ScleroID questionnaire
Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
Measured: Month 3
SSPRO
Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
Measured: Day 0
SSPRO
Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
Measured: Month 3
HAQ-DI questionnaire
Scales for measuring functional disability in SSc
Measured: Day 0
HAQ-DI questionnaire
Scales for measuring functional disability in SSc
Measured: Month 3
SHAQ questionnaire
Scales for measuring functional disability in SSc
Measured: Day 0
SHAQ questionnaire
Scales for measuring functional disability in SSc
Measured: Month 3
PROMIS-29 questionnaire
Questions regarding patient-perceived health.
Measured: Day 0
PROMIS-29 questionnaire
Questions regarding patient-perceived health.
Measured: Month 3
SF-12 questionnaire
Questions regarding patient-perceived health.
Measured: Day 0
SF-12 questionnaire
Questions regarding patient-perceived health.
Measured: Month 3
Anchoring questionnaire
Anchoring questionnaire
Measured: Day 0
Anchoring questionnaire
Anchoring questionnaire
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin CHAIGNE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888842
- Sponsor's protocol ID
- APHP241562
- Other IDs
- 2024-A02413-44
- Acronym
- FRESS-VQ
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Questionnaires on Disability, Health, and Quality of Life and Patient Assessment in Systemic Sclerosis - French Systemic Sclerosis Validated Questionnaires
- ClinicalTrials.gov ID
- NCT07888842
- Acronym / sponsor ID
- FRESS-VQ / APHP241562
- Conditions
- Scleroderma
- Keywords
- Systemic Scleroderma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 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.
The main objective of this study is to validate, in French, new questionnaires assessing disability, quality of life, and patient-reported outcomes in systemic sclerosis.
Detailed description
Systemic sclerosis is a disease characterized by the development of fibrotic lesions in the skin and deep internal organs such as the lungs, heart, and gastrointestinal tract, as well as vascular manifestations such as Raynaud's phenomenon, and, more rarely, pulp ischemia, pulmonary arterial hypertension (PAH), or renal crisis.
Eligible patients are the 250 patients with SSc. They will receive by mail an information sheet/patient consent form (in duplicate) along with an explanatory letter and the M0 and M3 questionnaires for their review. They will then be contacted by phone to answer any questions they may have (particularly regarding the study's objectives and procedures). If they agree to participate, they will be asked to complete and sign both copies of the consent form, complete the "M0" questionnaires, and return one copy of the signed consent form and the "M0" questionnaires by mail using the pre-addressed envelope provided for this purpose or in person. Patients will then return the completed self-administered questionnaires to M3 by mail (or by email or in person, depending on the patient's preference).
More recently, new disability and patient assessment questionnaires have been introduced internationally: the ScleroID (Becker MO 2022) and the SSPRO (Man A et al. 2017). While these questionnaires are recognized as useful for ScleroID internationally, their development did not include validation in French within a French population. In fact, these questionnaires have not been translated into French and therefore cannot be used without French-language validation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: QuestionnairesPatient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of French-speaking patients with systemic sclerosis who meet the 2013 ACR/EULAR classification criteria. The objective of this study is to validate French-language disability questionnaires for this patient population.
Key inclusion criteria (3 listed)
- Patients aged 18 years or older with SSc who meet the 2013 ACR/EULAR criteria (Van Hoogen et al., ARD 2013).
- Patients with a good understanding of the French language.
- Who have provided informed consent to participate in the study
Key exclusion criteria (4 listed)
- Patients with associated chronic disabling conditions: stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputees, etc.
- Patients with cognitive impairments
- Patients with difficulties understanding or speaking French
- Adults under legal guardianship
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 |
|---|---|---|
| QuestionnairesFrench-language questionnaires assessing disability, quality of life, and disease status. | Other | Patient |
Primary outcome
CSF 17 (Cochin 17-item Scleroderma Functional scale)
Time frame: Day 0
Questionnaire developed by the internal medicine department's research group for the SCISCIF studies to assess the patient's self-perceived health. The aim of this study is to validate French-language disability questionnaires for this patient population.
CSF 17 (Cochin 17-item Scleroderma Functional scale)
Time frame: Month 3
Questionnaire developed by the internal medicine department's research group for the SCISCIF studies to assess the patient's self-perceived health. The aim of this study is to validate French-language disability questionnaires for this patient population.
ScleroID questionnaire
Time frame: Day 0
Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
ScleroID questionnaire
Time frame: Month 3
Disability questionnaire, a scale requiring validation designed to assess global functional impairment associated with SSc
SSPRO
Time frame: Day 0
Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
SSPRO
Time frame: Month 3
Patient-reported assessment questionnaire; scale requiring validation, assessing the patient's evaluation of their disease.
HAQ-DI questionnaire
Time frame: Day 0
Scales for measuring functional disability in SSc
HAQ-DI questionnaire
Time frame: Month 3
Scales for measuring functional disability in SSc
SHAQ questionnaire
Time frame: Day 0
Scales for measuring functional disability in SSc
SHAQ questionnaire
Time frame: Month 3
Scales for measuring functional disability in SSc
PROMIS-29 questionnaire
Time frame: Day 0
Questions regarding patient-perceived health.
PROMIS-29 questionnaire
Time frame: Month 3
Questions regarding patient-perceived health.
SF-12 questionnaire
Time frame: Day 0
Questions regarding patient-perceived health.
SF-12 questionnaire
Time frame: Month 3
Questions regarding patient-perceived health.
Anchoring questionnaire
Time frame: Day 0
Anchoring questionnaire
Anchoring questionnaire
Time frame: Month 3
Anchoring questionnaire
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
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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.
Benjamin CHAIGNE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Scleroderma, run by Assistance Publique - Hôpitaux de Paris 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 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: opening soon, as of the sponsor's last update on 22 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 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?
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?
Contact Benjamin CHAIGNE, MD, PhD (00 33 1 58 41 2215, benjamin.chaigne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF 17 (Cochin 17-item Scleroderma Functional scale) (time frame: Day 0). The study lists 16 primary outcomes in all. 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 22 Oct 2026.