Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

Lung Cancer Clinical Trial

Official title:

Community-based Early Stage Lung Cancer Screening With Low-dose Computed Tomography in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02898441
• Other study ID #: 2013ZYJB0402
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 8, 2016
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: September 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 randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Low Dose Computed Tomography
LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.

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
Other	Nodule detection rate	Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm.	One year	No
Primary	Lung cancer incidence rate	Assess the number of lung cancer incidences after each round of screening in both arms. Compared the stage differences between screening arm and usual care arm.	5 years	No
Secondary	Lung cancer mortality	Assess lung cancer mortality in both arms within next 5 years after first round of screening.	5 years	No
Secondary	All-cause mortality	Assess all-cause mortality in both arms within next 5 years after first round of screening.	5 years	No