Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

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 intervention

    No investigational intervention. Participants receive standard clinical care. Clinical data, imaging/pathology information, and available biospecimens are collected for research.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: No investigational1 intervention

Trial outcomes

Primary outcomes

1

treatment response

Correlation/association between tissue or blood biomarker results and imaging/pathology/laboratory-based treatment response

Time frame
1 year
2

Association between candidate biomarker expression/levels and recurrence/progression risk

Correlation between biomarker results and recurrence/progression events, including PFS/RFS

Time frame
From baseline to end of follow-up

Secondary outcomes

1

Progression-free survival (PFS)

Time frame
1 year
2

Overall survival (OS)

Time frame
2 year
3

Dynamic changes in alpha-fetoprotein (AFP)

Time frame
1 year

Other outcomes

Sponsors and contacts

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