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RECRUITING
NCT07848750

InstaSure™ Non-Invasive Finger-Press Test for Hepatocellular Carcinoma

Sponsor: Beijing Municipal Administration of Hospitals

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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