Mastocytosis Clinical Trial
— MastCellHetOfficial title:
Study of Cellular Heterogeneity in Patients With Mastocytosis (MastCellHet) Mastocytosis Cell Heterogeneity
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.
Status | Not yet recruiting |
Enrollment | 26 |
Est. completion date | June 15, 2026 |
Est. primary completion date | June 8, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | marker | through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis and systemic mastocytosis will be identified compared with control sample | 24 month and one week | |
Other | marker - isolated cutaneous mastocytosis | through advanced imaging techniques (multiplexed imaging), marker in patients with isolated cutaneous mastocytosis will be identified compared with control sample | 24 month and one week | |
Other | marker - systemic mastocytosis | through advanced imaging techniques (multiplexed imaging), marker in patients with systemic mastocytosis will be identified compared with control sample | 24 month and one week | |
Primary | 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. | 24 month and one week | |
Secondary | 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. | 24 month and one week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01333293 -
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients
|
Phase 2/Phase 3 | |
Completed |
NCT01481909 -
Study on Mastocytosis for Rupatadine Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT00044122 -
Study of Factors Regulating Mast Cell Proliferation
|
||
Recruiting |
NCT06440148 -
Relationship Between Circulating Sclerostin and Bone Lesions in Patients With Mastocytosis
|
||
Recruiting |
NCT03340155 -
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
|
N/A | |
Not yet recruiting |
NCT05084872 -
Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients
|
Phase 2/Phase 3 | |
Terminated |
NCT01701843 -
Cromoglicate in Mastocytosis
|
Phase 2 | |
Completed |
NCT00831974 -
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
|
Phase 2 | |
Completed |
NCT00047918 -
Blood Factors in Mastocytosis and Unexplained Anaphylaxis and Flushing
|
N/A | |
Completed |
NCT00006413 -
Stem Cell Transplantation to Treat Systemic Mastocytosis
|
Phase 2 | |
Completed |
NCT00050193 -
Cause and Natural Course of Pediatric-Onset Mastocytosis
|
||
Completed |
NCT02620254 -
Mast Cell Connect: A Registry for Patients With Mastocytosis
|
||
Completed |
NCT00255346 -
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
|
Phase 2 | |
Completed |
NCT00001356 -
Characteristics of Mast Cells in Mastocytosis
|
N/A | |
Recruiting |
NCT06466889 -
Mastocytosis Registry (of Zurich)
|
||
Recruiting |
NCT05186753 -
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
|
Phase 2 | |
Completed |
NCT02478957 -
Treatment of Indolent Systemic Mastocytosis With PA101
|
Phase 2 | |
Recruiting |
NCT02450396 -
Pregnancy and Medically Assisted Conception in Rare Diseases
|
||
Completed |
NCT00038675 -
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate
|
N/A | |
Completed |
NCT00336076 -
Molecular Mechanisms and Diagnosis of Mastocytosis
|
N/A |