NCT02936804

Precision Diagnosis and Therapy for Early Stage Lung Cancer

Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60,000 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The present study is a single arm clinical trial aiming to improve the key technology in the diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening test will be carried out by a pre-specified protocol.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Low Dose Computed Tomography	LDCT was performed at baseline and 2 rounds of biennial repeated LDCT. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm. The management of abnormal nodules including precision diagnosis by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscope (ENB) and peripheral biomarkers, and precision therapy by intraoperative frozen section guided lung resection and ENB radiofrequency ablation.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2020-12-01
• First posted: 2016-10-18
• Last updated: 2016-10-19

Locations

1 site across 1 country: China