Study of Cellular Heterogeneity in Patients With Mastocytosis
ConditionMastocytosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject affiliated with a social security or insurance scheme
Subject who has given written consent to his participation in the study
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
scRNAseq
GeneticA blood test tube (only for scRNAseq, 2 tubes of 10 ml per patient)
two Skin biopsies
Procedure/Surgery2 skin biopsies from a lesional area
one Skin biopsies
Procedure/Surgery1 skin biopsies from a lesional area
Treatment groups
26 Participants
are divided into 4 treatment groupsGroup A: patients with isolated cutaneous mastocytosis with associated skin involvement - RNAseqOther 2 interventions
Group B: patients with mastocytosis indolent systemic with associated skin involvementOther 1 intervention
Group C: patients with isolated cutaneous mastocytosis with associated skin involvementOther 1 intervention
Group D: patients with mastocytosis indolent systemic with associated skin involvement - RNAseqOther 2 interventions
Trial outcomes
Primary outcomes
1
Study of the diversity of skin CD 45+ cells and circulating blood CD 34+ cells
This study aims to examine the diversity of CD 45+ cells in the skin and CD 34+ cells in the circulating blood in patients. The approach used will be single cell sequencing (scRNAseq) to identify the transcriptomic profiles of the different cell populations in these two types of mastocytosis.
Time frame
24 month and one weekSecondary outcomes
1
Study of common or differential transcripts
This part of the study will focus on analyzing common or differential genetic transcripts between patients with isolated cutaneous mastocytosis and those with systemic mastocytosis. The aim is to understand the underlying molecular differences between these two forms of the disease.
Time frame
24 month and one weekOther outcomes
1
marker
through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis and systemic mastocytosis will be identified compared with control sample
Time frame
24 month and one week2
marker - isolated cutaneous mastocytosis
through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis will be identified compared with control sample
Time frame
24 month and one week3
marker - systemic mastocytosis
through advanced imaging techniques (multiplexed imaging), marker in patients with systemic mastocytosis will be identified compared with control sample
Time frame
24 month and one weekSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: