Precision Diagnosis and Therapy for Early Stage Lung Cancer

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: Low Dose Computed Tomography

• Registration Number: NCT02936804
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-15
• Study First Submitted QC: 2016-10-15
• Last Update Submitted: 2016-10-17
• Study First Posted: 2016-10-18
• Last Update Posted: 2016-10-19
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60000

Inclusion Criteria

• Eligible participants were those aged 45-70 years, and with either of the following risk factors:

1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
2. malignant tumors history in immediate family members;
3. personal cancer history;
4. professional exposure to carcinogens;
5. long term exposure to second-hand smoke;
6. long term exposure to cooking oil fumes.

Exclusion Criteria

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening Arm	Low Dose Computed Tomography	Low Dose Computed Tomography (LDCT) was performed at baseline + 2 rounds of biennial repeated LDCT. Management of positive screening test will be carried out by a pre-specified protocol.

Primary Outcome Measures

Name	Time	Method
Lung cancer incidence rate	5 years	Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.

Secondary Outcome Measures

Name	Time	Method
Lung cancer disease free survival	5 years	Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.
Lung cancer mortality	5 years	Assess lung cancer mortality within next 5 years after first round of screening

Trial Locations

Locations (1)

Shanghai Chest hospital; 🇨🇳 Shanghai, Shanghai, China