NCT07848750 InstaSure™ Non-Invasive Finger-Press Test for Hepatocellular Carcinoma

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 40 participants in total. It began in 2026-06-30 with a primary completion date of 2026-12-01.

Brief 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.

Eligibility Criteria

Inclusion Criteria: HCC Group: * 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). Benign Liver Disease Group: \* Age ≥18 years, with no restriction on sex, with a clinical diagnosis of benign liver disease and hepatocellular carcinoma (HCC) excluded. Healthy Control Group: * Age ≥18 years, with no restriction on sex. * No history of liver disease, with normal liver function tests and liver ultrasonography. Exclusion Criteria: HCC Group: * 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. * Conditions affecting standardized fingertip sampling, including but not limited to severe skin lesions, fingertip injury, or inability to complete the standardized sampling procedure. * Poor compliance or inability to understand the study, cooperate with study procedures, or complete the study procedures as expected. * Any other condition that, in the investigator's judgment, may affect interpretation of the study results or participant safety. * Receipt of chemotherapy within 3 months before enrollment, or receipt within 1 month before enrollment of other anticancer treatment that may affect interpretation of nucleic acid signal testing results, including but not limited to targeted therapy, immunotherapy, or tumor radiotherapy. Benign Liver Disease Group: * History or current diagnosis of a pathologically confirmed malignancy, except for malignancies treated with curative intent and without recurrence for more than 5 years. * Pregnant or breastfeeding women. * Severe cardiac, pulmonary, or renal insufficiency, including New York Heart Association (NYHA) functional class III or higher heart failure or chronic kidney disease requiring regular dialysis. * Severe infection or active bleeding. * Mental or cognitive impairment resulting in inability to understand or sign the informed consent form. * Current participation in another interventional clinical trial. Healthy Control Group: * History or current diagnosis of a pathologically confirmed malignancy, except for malignancies treated with curative intent and without recurrence for more than 5 years. * Pregnant or breastfeeding women. * Severe cardiac, pulmonary, or renal insufficiency, including New York Heart Association (NYHA) functional class III or higher heart failure or chronic kidney disease requiring regular dialysis. * Severe infection or active bleeding. * Mental or cognitive impairment resulting in inability to understand or sign the informed consent form. * Current participation in another interventional clinical trial. * Recent history of liver disease.

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