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Clinical Study of Human HER2 Gene Amplification Assay Kit (Digital PCR Method)

Clinical Study of Human HER2 Gene Amplification Assay Reagents (Digital PCR Method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080432
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Breast cancer

Interventions

Sponsors

Qingyuan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with suspected breast cancer who had completed mammocentesis and pathology. (2) Positive sample: plasma samples are selected from patients whose breast cancer tumor tissue sections or pathological sections are positive for HER2 expression; (3) Negative sample: plasma samples are selected from patients whose breast cancer tumor tissue sections or pathological sections are negative for HER2 expression; (4) Agreed to sign an informed consent form.

Exclusion criteria

Exclusion criteria: Non-breast cancer patients; sample contamination; insufficient sample volume.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Kappa value;ROC curve;

Secondary

MeasureTime frame
Specificity;

Countries

China

Contacts

Public ContactLinhai Li

Qingyuan People's Hospital

mature303@126.com+86 188 1885 7232

Outcome results

None listed

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