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A multicenter research for Feasibility of blood ALK fusion detection in non-resectable patients with non-small cell lung cancer

A multicenter research for Feasibility of blood ALK fusion detection in non-resectable patients with non-small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024306
Enrollment
Unknown
Registered
2019-07-05
Start date
2018-11-01
Completion date
Unknown
Last updated
2019-07-15

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:Blood ctDNA
Index test:tissue/cell&#32
ctDNA

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Non-squamous non-small cell lung cancer patients: a) newly diagnosed untreated non-resectable late-stage (IIIB or IV) patients with ALK fusion-positive confirmed by histology or cytology; b) or ALK fusion-positive patients with ALK inhibitor failure, without further treatment yet (2) Fresh tissue or FFPE specimens were negative of sensitive mutations of EGFR detected by DNA sequencing or ARMS; (3) The subjects understand and voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: (1) Pathologically confirmed squamous cell carcinoma, or mixed non-small cell and small cell carcinoma, or mixed adenosquamous carcinoma with squamous cells as the primary component; (2) Patients who do not provide sufficient tissue or cells for EGFR and ALK genotyping; patients with positive EGFR mutations; patients with negative ALK fusion mutations; (3) Coagulopathy (PT time > 2 times the upper limit of normal or PLT < 50X10^9/L).

Design outcomes

Primary

MeasureTime frame
ALK fusion;

Countries

China

Contacts

Public ContactJun Zhao

Department of Thoracic Oncology, Beijing Cancer Hospital

ohjerry@163.com+86 010-88196456

Outcome results

None listed

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