Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Low Dose Computed Tomography

• Study Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Baohui Han, MD,PhD; Phone Number: 3301 86-21-62821990; Email: xkyyhan@gmail.com
      • Contact: Yanwei Zhang, MD,PhD; Phone Number: 86-15216687683; Email: zhangyw198691@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Screening Arm; LDCT was performed at baseline + 2 biennial repeated LDCT rounds	Device: Low Dose Computed Tomography; LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
No Intervention: Passive Arm; Eligible subjects were randomized to follow up in usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer mortality	Assess lung cancer mortality in both arms within next 5 years after first round of screening.	5 years
All-cause mortality	Assess all-cause mortality in both arms within next 5 years after first round of screening.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nodule detection rate	Assess nodule detection rate, and the types and sizes of nodules detected in LDCT screening arm.	One year

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Principal Investigator: Baohui Han, MD, PhD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: lung cancer screening; low-dose CT; high-risk population
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2013ZYJB0402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED