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Non-small cell lung cancer driver gene detection specimen type expansion study-sputum supernatant cfDNA driver gene mutation detection

NSCLC sputum supernatant cfDNA driver gene mutation detection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034788
Enrollment
Unknown
Registered
2020-07-19
Start date
2020-07-16
Completion date
Unknown
Last updated
2020-07-20

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

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samples

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: If it satisfies 1 and any of 2-6 can be included in the group. 1. Patients who can obtain biopsy or other cytological specimens of sputum, and use this specimen for gene change detection at the same time. The detection reagents must use the reagents approved by the authority, including arms method and ngs method. For ALK gene and other fusion gene detection methods, including: Ventana ALK (d5f3) immunohistochemical detection, fish or RT-PCR method; 2. Patients with NSCLC in stage IIIB-IV; 3. NSCLC patients with recurrence or metastasis were not confirmed by targeted drug therapy after surgery; 4. Patients with advanced NSCLC treated with EGFR small molecule inhibitors of the first generation to the third generation and alk inhibitors from the first generation to the third generation; 5. Other targeted drugs are used to treat patients with drug resistance; 6. Normal control group, no tumor population, no tumor population after follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who failed to obtain tumor tissue and cytological specimens for definite pathological diagnosis; 2. The patients who did not obtain the results of non-small cell lung cancer driver gene test were not found; 3. Diagnosis of non-small cell lung cancer patients with respiratory infection; 4. Sputum samples were obtained and diagnosed as unqualified sputum samples by cytology and pathology. Unqualified sputum samples were defined as no epithelial cells or phagocytes in sputum smears under microscope (according to the results of previous studies, the sensitivity of driving gene change detection of such samples was 0).

Design outcomes

Primary

MeasureTime frame
Driver gene mutation results;

Secondary

MeasureTime frame
The positive rate and negative rate of driver gene between natural sputum group and induced sputum group. The sensitivity, specificity, PPV, NPV and concordance of sputum sample compared with tumor sample.;PFS and OS of patients after targeted therapy;

Countries

China

Contacts

Public ContactZheng Wang

Beijing Hospital

wangzhengmay@163.com+86 18611515915

Outcome results

None listed

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