Relationship Between FGF19 Overexpression and Disease Prognosis

NCT ID: NCT06938451

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-12-31

Brief Summary

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A real-world study of FGF19 overexpression status and treatment outcome and prognosis in advanced hepatocellular carcinoma

Detailed Description

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This is a real-world, single-arm, observational study to collect information on the diagnosis and prognosis of hepatocellular carcinoma patients with previous tissue samples in routine clinical practice, and to detect the expression of FGF19 expression in tissue samples, with a view to discovering prognostic and predictive markers for advanced hepatocellular carcinoma The treatment protocol of this study follows the clinical practice and does not set any limitations on the interventions for patients.

In this study, real-world liver tissue samples will be collected from patients with hepatocellular liver cancer after surgical resection, and the samples will be sent to a third-party pathology slice reviewer for review, and a report on the FGF19 expression results will be returned to the project team. Simultaneously collect clinical data of the patient.

According to the principle of clinical routine diagnosis and treatment, the patient's imaging data were collected, and the imaging of the 2-month period was evaluated, and whether the disease progressed was judged according to the RESCIST v1.1 standard. Every two months will be an observation cycle. Each subject will be followed from the first treatment until disease progression or change of drug regimen.

Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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inspection team

Surgically resected liver tissue samples were sent to a third-party pathology slice reviewer for uniform reading, and a report on FGF19 expression results was issued and returned to the project team. The clinical data of the patient will be collected at the same time.

Intervention Type OTHER

This is an observational study and does not involve an intervention

Interventions

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This is an observational study and does not involve an intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years on the day of signing the informed consent form
* Histologically or clinically confirmed diagnosis of intermediate to advanced HCC
* Adequate tissue samples of previous liver cancer
* Expected survival of more than 3 months

Exclusion Criteria

* Fibrous laminae or sarcomatoid HCC or mixed HCC-ICC, or other rare non-HCC pathologic subtypes
* Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZHAO YING

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ZHAOYING Resident physician, phD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Locations

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Beijing Tsinghua Changgung Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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ZHAOYING Resident physician, phD

Role: CONTACT

86+13810943515

Facility Contacts

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ZHAO YING ZHAOYING, phD

Role: primary

86+13810943515

Other Identifiers

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V1.0 20250309

Identifier Type: -

Identifier Source: org_study_id

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