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Development of a new companion diagnostic kit for antineoplastics

Development and performance validation of companion diagnostic kits for antineoplastic agents

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109600
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Solid tumor

Interventions

Gold Standard:FISH was the gold standard for CNV detection and Sanger sequencing was the gold standard for mutation detection.
Index test:Quantitative polymerase chain reaction kit

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.He/She had undergone genetic testing for cancer in the Precision Medicine Laboratory of our hospital; 2.Have a tumor tissue specimen (e.g. , formalin paraffin-embedded FFPE tissue or fresh tissue) available for PCR testing; 3.Complete clinical data are available;

Exclusion criteria

Exclusion criteria: 1.Sample quality does not meet QPCR testing requirements (e.g. , too little tissue or severe degradation of extracted DNA); 2.No corresponding FISH or Sanger sequencing or next-generation sequencing results were available for alignment.

Design outcomes

Primary

MeasureTime frame
Gene amplification;Point Mutation of gene;

Countries

China

Contacts

Public ContactJiabian Lian

The First Affiliated Hospital of Xiamen University

faster_lian@xmu.edu.cn+86 592 2139659

Outcome results

None listed

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