Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT04532151
Eligibility Criteria:
IInclusion criteria
* Major subject (age ≥ 18 years)
* Male or female subject
* Subject affiliated to a social health insurance scheme
* Subject having signed an informed consent
* Subject having been informed of the results of the prior medical examination
Inclusion criteria specific to each group
* Group 1 "Early SSc group": Patients with SSc according to ACR / EULAR criteria (2013) early onset \<2 years and without clinical cutaneous sclerosis
* Group 2 "Established SSc group": Patients with SSc according to ACR / EULAR criteria (2013) with cutaneous sclerosis
* Group 3 "Control group": Hospitalized patients in the Rheumatology Department of the University Hospitals of Strasbourg, excluding connective tissue disease
Exclusion criteria:
* Non-inclusion criteria for patients / controls in 3 groups
* Subject having undergone a physical treatment (radiotherapy, surgical intervention ...) on the cutaneous sites studied
* Subjects who received general corticosteroid therapy in the last 3 months
* Subjects being treated with topical corticosteroids on the different cutaneous sites studied
* Impossibility to give clear information of subject (subject in emergency situation, subject with difficulties of understanding ...)
* Subject in exclusion period (determined by previous or current study),
* Subject under the protection of justice, guardianship or curatorship
* Pregnancy (on declaration of the patient)
Non-inclusion criteria specific to each group
\- Group 1 "Early SSc group": Patients with SSc and having a clinical cutaneous sclerosis
\- Group 2 "Established SSc group": Patients with criteria for another systemic autoimmune disease
\- Group 3 "Control group":
* Subjects with scleroderma,
* Subjects with Raynaud's phenomenon
* Subjects with other sclerosing disease (morphea, Shulman,…)
* Diabetic subjects
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04532151
Study Brief:
Protocol Section:
NCT04532151