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Peripheral Blood KIT-D816V Mutation in Adult Systemic Mastocytosis

NCT07562542 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2028-05-19
Completion
2028-07-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562542 on ClinicalTrials.gov