NCT04159337

NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

Detailed description

Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
OTHER	The method of gene mutation detection	All samples were detected by large-panel, whereas some of which were also detected by WES.

Timeline

• Start date: 2019-08-30
• Primary completion: 2022-01-01
• Completion: 2022-05-31
• First posted: 2019-11-12
• Last updated: 2019-11-12

Locations

1 site across 1 country: China