Trials
Search / Trial NCT06432556

Study of Cellular Heterogeneity in Patients With Mastocytosis

Launched by UNIVERSITY HOSPITAL, TOULOUSE · May 21, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Mastocytosis Mast Cells Cellular Heterogeneity Cd 45+ Cd 34+

ClinConnect Summary

Mastocytosis is a rare disease caused by abnormal mast cell accumulation/proliferation. Its clinical features are very heterogeneous. Among adult patients, 15% present an isolated cutaneous mastocytosis (CM), while 85% of them present a systemic mastocytosis (SM) with cutaneous lesions. In addition, regardless of the diagnosis (i.e., CM or SM), it is frequent to observe mast cell-dependent symptoms of variable severity, ranging from gastrointestinal discomfort to life-threatening reactions. To date, the origin of such heterogeneous manifestations in adult patients is still elusive. Research...

Gender

ALL

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

Trial Officials

Cristina Bulai Livideanu, MD

Principal Investigator

Toulouse univiversity hospital

About University Hospital, Toulouse

The University Hospital of Toulouse is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific inquiry with comprehensive clinical services. Its multidisciplinary team of healthcare professionals collaborates with renowned researchers to facilitate pioneering studies across various medical fields, aiming to enhance treatment options and improve patient outcomes. As a prominent institution in the region, the University Hospital of Toulouse is committed to fostering an environment of excellence in both education and research within the healthcare community.

Locations

Toulouse, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0