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InstaSure™ Non-Invasive Finger-Press Test for Hepatocellular Carcinoma
Sponsor: Beijing Municipal Administration of Hospitals
Summary
This prospective observational case-control study evaluates the InstaSure™ Non-Invasive Finger-Press Test for hepatocellular carcinoma (HCC). The study plans to enroll 40 participants, including 30 patients with HCC, 5 patients with benign liver disease, and 5 healthy controls. Finger-tip skin cell samples will be collected non-invasively and tested for HCC-associated CCND1 and CDKN2A/P16 eccDNA signals. The primary objective is to preliminarily evaluate the sensitivity and specificity of the test in distinguishing patients with HCC from non-HCC controls. The study will also assess the feasibility of the testing procedure and explore the association between eccDNA signals and clinical characteristics of HCC, providing preliminary data for subsequent larger-scale clinical studies.
Official title: InstaSure™ Non-Invasive Finger-Press Point-of-Care Screening Test for Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2026-06-30
Completion Date
2026-12-01
Last Updated
2026-09-30
Healthy Volunteers
Yes
Conditions
Interventions
InstaSure™ Non-Invasive Finger-Press Test
Finger-tip skin cell samples are collected non-invasively using a finger-press procedure and tested for HCC-associated CCND1 and CDKN2A/P16 eccDNA signals. Test results are compared with the clinical reference diagnosis to evaluate the ability of the test to distinguish participants with HCC from non-HCC controls.
Locations (1)
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China