Precision Diagnosis and Therapy for Early Stage Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02936804
• Other study ID #: Chest002
• Status: Not yet recruiting
• Phase: N/A
• First received: October 15, 2016
• Last updated: October 17, 2016
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: Shanghai Chest Hospital
• Contact: Baohui Han, MD, PhD
• Phone: 86-21-62821990
• Email: xkyyhan[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60000
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Chest hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer incidence rate	Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.	5 years	No
Secondary	Lung cancer disease free survival	Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.	5 years	No
Secondary	Lung cancer mortality	Assess lung cancer mortality within next 5 years after first round of screening	5 years	No