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A Study on the Current Status of Real-World Detection of Biomarkers for Intrahepatic Cholangiocarcinoma in China

A Study on the Current Status of Real-World Detection of Biomarkers for Intrahepatic Cholangiocarcinoma in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100377
Enrollment
Unknown
Registered
2025-04-08
Start date
2024-09-10
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

observation group:None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with intrahepatic cholangiocarcinoma histologically from January 1, 2021, to July 1, 2024; 2.At the time of sample collection, the patients were over 18 years of age; 3.By the time of testing, the formalin-fixed paraffin-embedded (FFPE) samples had been stored for no more than 5 years; 4.Patients who, according to existing test reports, are determined to require re-examination can provide sufficient tumor tissue samples for centralized testing at the Molecular Pathology Center of Zhongshan Hospital; 5.Biological sample donors have signed an informed consent form, agreeing that the donated samples and related information can be used for all medical research;

Exclusion criteria

Exclusion criteria: 1.Patients for whom histology cannot definitively diagnose intrahepatic cholangiocarcinoma; 2.Patients whose tissue samples have a tumor cell content below 20%, which does not meet the testing requirements; 3.Those who cannot provide molecular detection results of intrahepatic cholangiocarcinoma biomarkers by FISH or other methods;

Design outcomes

Primary

MeasureTime frame
FGFR gene positive;

Secondary

MeasureTime frame
IDH1/2 gene positive;Her-2 Gene Amplification or Protein Overexpression;Claudin18.2 Gene Expression or Protein Expression;

Countries

China

Contacts

Public ContactJi Yuan

Zhongshan Hospital, Fudan University

ji.yuan@zs-hospital.sh.cn+86 136 8185 8366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026