About this trial
Observational Model: Cohort Time Perspective: Other (prospective and retrospective data/sample collection) Primary Purpose: Other (biomarker validation for treatment response and recurrence prediction) Biospecimen Retention: Samples With DNA Biospecimen Description: Residual tissue, wax blocks/slides, residual puncture/surgical materials, and residual blood from routine testing; additional peripheral blood, 5-10 mL per collection, may be collected if needed after separate informed consent.
Enrollment: 500 (anticipated) Study Population: Adult patients with HCC confirmed by imaging and/or pathology at participating centers, receiving standard antitumor therapy and planned for systematic follow-up.
Sampling Method: Not specified in the protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Male or female aged ≥18 years. 2. HCC confirmed by imaging and/or pathology according to current Chinese guidelines.
Disqualifiers
1. Active malignancy at other sites, or history of other malignancy within 5 years, except cured in situ carcinoma and basal cell skin carcinoma.
Trial population
This study uses a multicenter, non-interventional observational design with both prospective and retrospective data and sample collection. The study does not change the patient's established diagnosis or treatment plan and does not assign investigational drugs or treatment pathways. Clinical data, imaging and pathology information, treatment outcomes, and available biospecimens are collected under a unified protocol at baseline, treatment/sample recording, efficacy and dynamic monitoring, and outcome/long-term follow-up
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.
Other interventionNo investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.
Treatment groups
Trial outcomes
Primary outcomes
treatment response
Correlation/association between tissue or blood biomarker results and imaging/pathology/laboratory-based treatment response
Association between candidate biomarker expression/levels and recurrence/progression risk
Correlation between biomarker results and recurrence/progression events, including PFS/RFS
Secondary outcomes
Progression-free survival (PFS)
Overall survival (OS)
Dynamic changes in alpha-fetoprotein (AFP)
Sponsors and contacts
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