Hepatocellular CarcinomaNCT07848750
InstaSure™ Non-Invasive Finger-Press Test for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- InstaSure™ Non-Invasive Finger-Press Test
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: InstaSure™ Non-Invasive Finger-Press Point-of-Care Screening Test for Hepatocellular Carcinoma
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.
Read the detailed description
The study will enroll 40 participants from Beijing Ditan Hospital, Capital Medical University, including 30 patients with hepatocellular carcinoma (HCC), 5 patients with benign liver disease, and 5 healthy controls. HCC will be confirmed by histopathological diagnosis or clinical imaging diagnosis according to established diagnostic criteria. Finger-tip skin cell samples will be collected using a non-invasive finger-press procedure and tested with the InstaSure™ test for HCC-associated CCND1 and CDKN2A/P16 eccDNA signals. Test results will be compared with the clinical reference diagnosis to estimate sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and the Youden index. The study will also evaluate sampling convenience, testing time, and clarity of result interpretation, and explore associations between eccDNA signals and HCC clinical characteristics such as tumor stage, tumor size, and AFP level. The findings will be used as exploratory evidence to support sample-size estimation and procedural optimization for subsequent larger-scale clinical studies.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- InstaSure™ Non-Invasive Finger-Press Test
- Keywords
- Hepatocellular Carcinoma, HCC, Liver Cancer, Finger-Press Test
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InstaSure™ Non-Invasive Finger-Press TestDiagnostic test
Also called InstaSure™ HCC-Associated CYCLIN D1 & CDKN2A/P16 eccDNA Finger-Press Point-of-Care Screening 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: InstaSure™ Non-Invasive Finger-Press Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (at the time of study testing)
Secondary outcomes (1)
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.
Measured: Day 1 (at the time of study testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848750
- Sponsor's protocol ID
- DTEC-KY2026-085-02
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InstaSure™ Non-Invasive Finger-Press Point-of-Care Screening Test for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07848750
- Acronym / sponsor ID
- DTEC-KY2026-085-02
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, HCC, Liver Cancer, Finger-Press Test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will enroll 40 participants from Beijing Ditan Hospital, Capital Medical University, including 30 patients with hepatocellular carcinoma (HCC), 5 patients with benign liver disease, and 5 healthy controls. HCC will be confirmed by histopathological diagnosis or clinical imaging diagnosis according to established diagnostic criteria. Finger-tip skin cell samples will be collected using a non-invasive finger-press procedure and tested with the InstaSure™ test for HCC-associated CCND1 and CDKN2A/P16 eccDNA signals. Test results will be compared with the clinical reference diagnosis to estimate sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and the Youden index. The study will also evaluate sampling convenience, testing time, and clarity of result interpretation, and explore associations between eccDNA signals and HCC clinical characteristics such as tumor stage, tumor size, and AFP level. The findings will be used as exploratory evidence to support sample-size estimation and procedural optimization for subsequent larger-scale clinical studies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HCC Group | – | Diagnostic Test: InstaSure™ Non-Invasive Finger-Press TestParticipants 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. |
| Benign Liver Disease Group | – | Diagnostic Test: InstaSure™ Non-Invasive Finger-Press TestParticipants with benign liver disease and without evidence of hepatocellular carcinoma. A total of 5 participants are planned for this group. |
| Healthy Control Group | – | Diagnostic Test: InstaSure™ Non-Invasive Finger-Press TestHealthy participants without known liver disease or hepatocellular carcinoma. A total of 5 participants are planned for this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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, with a clinical diagnosis of benign liver disease and hepatocellular carcinoma (HCC) excluded.
- Age ≥18 years, with no restriction on sex.
- No history of liver disease, with normal liver function tests and liver ultrasonography.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InstaSure™ Non-Invasive Finger-Press TestAlso: InstaSure™ HCC-Associated CYCLIN D1 & CDKN2A/P16 eccDNA Finger-Press Point-of-Care Screening 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 test | Benign Liver Disease Group, HCC Group, Healthy Control Group |
Primary outcome
Diagnostic Performance of the InstaSure™ Non-Invasive Finger-Press Test for HCC
Time frame: Day 1 (at the time of study testing)
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.
1 secondary outcome
Area Under the Receiver Operating Characteristic Curve (AUC)
Time frame: Day 1 (at the time of study testing)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Beijing Municipal Administration of Hospitals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghui Li, Dr (+8613693259096, wuhm2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of the InstaSure™ Non-Invasive Finger-Press Test for HCC (time frame: Day 1 (at the time of study testing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.