Precision Diagnosis and Therapy for Early Stage Lung Cancer

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Low Dose Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02936804

Chest002

Details and patient eligibility

About

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.

Enrollment: 60,000 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60,000 participants in 1 patient group

Screening Arm

Experimental group

Description:

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.

Treatment:

Device: Low Dose Computed Tomography