Clinical Trial

Peripheral Blood KIT-D816V Mutation in Adult Systemic Mastocytosis

Study acronym: PB-KIT in SM
Recruiting
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Summary
This observational study aims to evaluate the diagnostic value and clinical utility of detecting the KIT-D816V mutation in the peripheral blood of adult patients with systemic mastocytosis (SM), using droplet digital PCR (ddPCR). Currently, the diagnosis of SM relies heavily on invasive bone marrow biopsies. This study will determine whether highly sensitive ddPCR testing of peripheral blood could provide a reliable, minimally invasive alternative for detecting the KIT-D816V mutation, which is a key driver of the disease and a major diagnostic criterion. The results could optimize the diagnostic process and continuous monitoring of adult SM patients.
Trial Details
NCT Number NCT07562542
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Systemic Mastocytosis, KIT-D816V Mutation
Enrollment 50 participants
Start Date 2025-05-19
Primary Completion 2028-05-19 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-01