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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT06432556
Eligibility Criteria:
Inclusion Criteria:
* Criteria related to the study population:
* Subject affiliated with a social security or insurance scheme
* Subject who has given written consent to his participation in the study
* Criteria related to the studied pathology:
* Subject diagnosed with isolated cutaneous or indolent systemic mastocytosis with associated skin involvement defined according to World Health Organization criteria (and/or international criteria for cutaneous mastocytosis)
* Subjects whose KIT mutation status is known in the skin, bone marrow, and blood
Exclusion Criteria:
* Criteria related to the study population:
* Sun exposure of the biopsied areas expected within the 4 weeks preceding
* Subjects who have had exposure to sunlight or artificial UV radiation within the 2 weeks preceding inclusion at the biopsied areas
* Adult patients under legal protection, guardianship, or curatorship
* Pregnant or lactating women
* Criteria related to the studied pathology:
* Subjects with an advanced version of the pathology or advanced systemic mastocytosis (SAMA)
* Subjects with a known history of allergy or intolerance to local anesthetics
* Subjects who have previously shown abnormalities in skin healing or any other contraindication to skin biopsy
* Subjects with recognized addiction to alcoholism or drug abuse
* Subjects with a hereditary or acquired disorder of hemostasis
* Subjects with a severe or acute chronic condition judged by the investigator as incompatible with the trial
* Subjects presenting a clinically incompatible immune deficiency with the study
* Patients without a well-established diagnosis of mastocytosis
* Patients included in a therapeutic study for indolent systemic mastocytosis
* Treatment-related criteria:
* Any topical or systemic treatment for atopic dermatitis (including phototherapy) ongoing or stopped at least 14 days before the inclusion visit
* Systemic corticosteroids within the 4 weeks preceding the inclusion visit
* Ongoing systemic treatment likely to interfere with the healing process
* Subjects who have undergone physical treatment (radiotherapy, etc.) on the biopsy area in the past 6 months
* History of treatment or concomitant treatment that may interfere with the conduct of the study as determined by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06432556
Study Brief:
Protocol Section:
NCT06432556