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Human EGFR/ALK Mutation Combo Detection Kit (Hybrid Capture-Based Next Generation Sequencing)

Human EGFR/ALK Mutation Combo Detection Kit (Hybrid Capture-Based Next Generation Sequencing) (HPLS2019-01)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039940
Enrollment
Unknown
Registered
2020-11-14
Start date
2019-04-17
Completion date
Unknown
Last updated
2021-02-22

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

Interventions

Gold Standard:Gold Standard: Sanger sequencing Reference Standard:cobas EGFR Mutation Test V2 (Roche Diagnostics GmbH,State instrument injection 20193401515) and Vysis ALK Break Apart FISH Probe Kit (
EGFR/ALK&#32
Combo&#32
Detection&#32
Kit&#32
(Hybrid&#32
Capture-Based&#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. Subjects aged 18 years or above were selected, regardless of gender; 2. Subjects with clinically diagnosed non-small cell lung cancer (NSCLC) by cytology or histology; 3. More than 10 pieces of wax roll, 3-5 µ m thick samples, more than 2 pieces of white pieces, tumor cells accounted for more than 20%, necrosis tissue area < 10%. 4. Select samples within 2 years; 5. Interference samples: samples of small cell lung cancer or benign tumor.

Exclusion criteria

Exclusion criteria: 1. The sample size is insufficient to meet the test requirements; 2. Samples not kept in accordance with the instructions; 3. Samples with incomplete case information (including gender, age, diagnosis results, imaging diagnosis, pathological diagnosis and other demographic data, etc.) 4. Samples that the researchers think need to be excluded.

Design outcomes

Primary

MeasureTime frame
Positive coincidence rate;Negative coincidence rate;The total coincidence rate;Kappa value;

Countries

China

Contacts

Public ContactCuicui Wang

HaploX Biotechnology Co., Ltd.

wangcc@haplox.com+86 13269211794

Outcome results

None listed

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