InstaSure Non-Invasive Finger-Press Test for HCC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational case-control study enrolling 40 participants at Beijing Ditan Hospital. Participants include 30 with hepatocellular carcinoma, 5 with benign liver disease, and 5 healthy controls. The finger-press technique collects skin-cell samples and tests for HCC-associated eccDNA signals (CCND1 and CDKN2A/P16). The primary goal is to estimate how well the test distinguishes HCC from non-HCC and to assess feasibility, with secondary exploration of associations between signals and clinical features like tumor stage, size, and AFP. Results will inform sample-size planning and procedural optimization for future larger studies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Ditan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Minghui Li, Dr
• Email: wuhm2000@sina.com
• Phone: +8613693259096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.