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Human HER2 Gene Amplification Assay Kit (Digital PCR Method)-Automated Digital PCR Analyzer Clinical Trial

Human HER2 Gene Amplification Assay Kit (Digital PCR Method)-Automated Digital PCR Analyzer Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081553
Enrollment
Unknown
Registered
2024-03-05
Start date
2024-03-17
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Breast cancer

Interventions

Sponsors

Jingzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with advanced (Stage III or IV), recurrent or metastatic breast cancer, with planned or completed mammocentesis and immunohistochemical testing; (2) Patients with complete clinicopathologic information; (3) Have signed the informed consent form as required.

Exclusion criteria

Exclusion criteria: (1) Patients with conditions considered by the investigator to be inappropriate for participation, such as severe anemia or high risk of hemorrhage that make it inappropriate to draw peripheral blood for testing; (2) Patients with other concurrent malignancies.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Kappa value;ROC curve;

Countries

China

Contacts

Public ContactChengbin Li

Jingzhou Central Hospital

2388879241@qq.com+86 181 0716 7525

Outcome results

None listed

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