Study of Cellular Heterogeneity in Patients With Mastocytosis (NCT06432556) | Clinical Trial Compass
UnknownNot Applicable
Study of Cellular Heterogeneity in Patients With Mastocytosis
France26 participantsStarted 2024-06-01
Plain-language summary
This study will aim to study the heterogeneity of skin-resident mast cells and of blood circulating hematopoietic progenitors in patients suffering from isolated Cutaneous Mastocytosis and from systemic Mastocytosis with skin lesions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study of the diversity of skin CD 45+ cells and circulating blood CD 34+ cells