Precision Diagnosis and Therapy for Early Stage Lung Cancer

NCT ID: NCT02936804

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Screening Arm

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.

Group Type: EXPERIMENTAL

Low Dose Computed Tomography

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Baohui Han

: Vice-President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baohui Han, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Baohui Han, MD, PhD

Role: CONTACT

xkyyhan@gmail.com

86-21-62821990 ext. 3301

Yanwei Zhang, MD, PhD

Role: CONTACT

zhangyw198691@163.com

86-21-62821990 ext. 3306

Facility Contacts

Baohui Han, MD,PhD

Role: primary

xkyyhan@gmail.com

86-21-62821990 ext. 3301

Yanwei Zhang, MD,PhD

Role: backup

zhangyw198691@163.com

86-21-62821990 ext. 3306

Other Identifiers

Chest002

Identifier Type: -

Identifier Source: org_study_id