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

NCT07848750 | Recruiting

• 1 other identifier: DTEC-KY2026-085-02
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; HCC; Liver Cancer; Finger-Press Test

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (at the time of study testing)

Secondary Outcomes (1)

• Area Under the Receiver Operating Characteristic Curve (AUC)

  Day 1 (at the time of study testing)

Study Arms (3)

HCC Group

Participants with hepatocellular carcinoma (HCC) confirmed by histopathology or clinical imaging according to established diagnostic criteria. A total of 30 participants are planned for this group.

Diagnostic Test: InstaSure™ Non-Invasive Finger-Press Test

Benign Liver Disease Group

Participants with benign liver disease and without evidence of hepatocellular carcinoma. A total of 5 participants are planned for this group.

Diagnostic Test: InstaSure™ Non-Invasive Finger-Press Test

Healthy Control Group

Healthy participants without known liver disease or hepatocellular carcinoma. A total of 5 participants are planned for this group.

Diagnostic Test: InstaSure™ Non-Invasive Finger-Press Test

Interventions

InstaSure™ Non-Invasive Finger-Press Test DIAGNOSTIC_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.

Also known as: InstaSure™ HCC-Associated CYCLIN D1 & CDKN2A/P16 eccDNA Finger-Press Point-of-Care Screening Test

Benign Liver Disease Group; HCC Group; Healthy Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Minghui Li, Dr

CONTACT

+8613693259096; wuhm2000@sina.com

Lu Zhang, Dr

CONTACT

+8613581975577; zhanglu1218@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 30, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)