NCT05023746

Clinical Evaluation of Genetron Lung Cancer Panel in Non-small Cell Lung Cancer Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,052 (actual)
• Sponsor: Genetron Health · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this trail is to evaluate the performance of Genetron lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing method.

Detailed description

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The safety and effectiveness of this panel are confirmed and evaluated. Meanwhile, the accuracy of this panel for the following drug companion diagnostic tests: EGFR gene 19 exon deletion and L858R point mutation in gefitinib tablets, erlotinib hydrochloride and icotinib hydrochloride tablets, T790M point mutation in methanesulfonate acid osimertinib tablets, ALK gene fusion in crizotinib capsules. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Genetron lung cancer panel	Follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.

Timeline

• Start date: 2018-08-30
• Primary completion: 2019-09-09
• Completion: 2019-09-17
• First posted: 2021-08-27
• Last updated: 2021-09-01

Locations

4 sites across 1 country: China