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.
Age ≥18 years, with no restriction on sex.
Primary hepatocellular carcinoma (HCC) confirmed by histopathology or clinical imaging according to the diagnostic criteria specified in the National Health Commission Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).
Age ≥18 years, with no restriction on sex.
No history of liver disease, with normal liver function tests and liver ultrasonography.
History or current diagnosis of other pathologically confirmed malignancies, except for malignancies treated with curative intent and without recurrence for more than 5 years.
Pregnant or breastfeeding women.
Severe systemic diseases, including but not limited to severe cardiac, pulmonary, or renal insufficiency, or uncontrolled acute systemic infection.
Receipt of blood transfusion, immunosuppressive therapy, or other interventions that may significantly affect interpretation of the test results within 1 month before enrollment.
The study population will consist of adults aged 18 years or older recruited from the outpatient and inpatient populations of the Liver Disease Center at Beijing Ditan Hospital, as well as hospital staff. The study includes three groups: participants with hepatocellular carcinoma (HCC), participants with benign liver disease without HCC, and healthy controls without a history of liver disease.
Case-control
Retrospective
InstaSure™ Non-Invasive Finger-Press Test
Diagnostic testFinger-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.
Diagnostic Performance of the InstaSure™ Non-Invasive Finger-Press Test for HCC
Diagnostic performance of the InstaSure™ test for distinguishing participants with HCC from non-HCC controls will be evaluated using sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy, with the clinical reference diagnosis used as the reference standard.
Area Under the Receiver Operating Characteristic Curve (AUC)
The area under the receiver operating characteristic curve (AUC) will be calculated to evaluate the ability of the InstaSure™ test to discriminate participants with HCC from non-HCC controls.
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