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The detection of EGFR/ALK/ROS1/RET/KRAS/NRAS/PIK3CA/BRAF/HER2/MET gene mutations in human(Reversible Terminator Sequencing)

The detection of EGFR/ALK/ROS1/RET/KRAS/NRAS/PIK3CA/BRAF/HER2/MET gene mutations in human(Reversible Terminator Sequencing)

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053481
Enrollment
Unknown
Registered
2021-11-22
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Non-small cell lung cancer(NSCLC)

Interventions

Gold Standard:Clinical trials verifying the consistency of AmoyDx Essential NGS Panel (Reversible Terminator Sequencing)
Index test:the&#32
detection&#32
of&#32
EGFR/ALK/ROS1/RET/KRAS/NRAS/PIK3CA/BRAF/HER2/MET&#32
gene&#32
in&#32
human(Reversible&#32
Sequencing)&#32

Sponsors

Beijing Chest Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with diagnosed non-small cell lung cancer; 2. The age of the subjects is >=18 years old; the gender is not limited; 3. Sufficient tissue samples can be provided to meet the research requirements: 8~10 slices with a thickness of 5µm; 4. The tumor cell content in the tissue specimen should be >=20%; 5. The sample storage period shall not exceed 18 months.

Exclusion criteria

Exclusion criteria: 1. Samples with incomplete or untraceable traceability information; 2. Other situations that the investigator considers unsuitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
gene mutation;

Countries

China

Contacts

Public ContactChe Nanying

Beijing Chest Hospital affiliated to Capital Medical University

cheny0448@163.com+86 10 89509381

Outcome results

None listed

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