Bronchoscopy Screening for High-risk Population of Lung Cancer With Severe Smoking With Negative LDCT Screen

Jiayuan Sun

Status: Unknown

Conditions: Heavy Smoking

Treatments: Procedure: white light bronchoscopy & autofluorescence bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04413669

SHCHE201907

Details and patient eligibility

About

Based on the previous work of LDCT screening, in order to improve the screening rate of central lung cancer for LDCT negative and severe smokers, the investigators plan to conduct China's first large-scale fluorescent bronchoscopy screening test.

Full description

CT scan is a commonly used method for clinical screening for early lung cancer, but research shows that LDCT scan has a higher detection rate for peripheral lesions (often adenocarcinoma), and a lower detection rate for central lung cancer (mostly squamous cell carcinoma). Fluorescent bronchoscopy uses the principle of differentiating fluorescence in different tissues to distinguish normal parts from diseased parts. It is often used for screening of central early lung cancer.Based on the results of the investigator's previous research, the investigators plan to conduct a second round of community screening-bronchoscopy screening, and perform white light bronchoscopy and autofluorescence bronchoscopy screening for high-risk groups of lung cancer with heavy smoking (≥400 years) and no obvious lung nodules.

Enrollment: 400 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 45-75 years;
2. have a smoking history of ≥20 pack years; if participants quit smoking, it should be <15 years;
3. Chest LDCT examination within one and a half years without obvious abnormalities or calcified nodules or non-calcified nodules and no signs of malignancy

Exclusion criteria

1. Non-smokers or mild smokers;
2. There are contraindications to bronchoscopy, such as active hemoptysis, unstable angina pectoris, coagulation dysfunction, anesthesia allergy, etc .;
3. Refusing to sign informed consent;
4. The operator believes that the patient has other conditions that are not suitable for bronchoscopy.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

white light bronchoscopy and autofluorescence bronchoscopy

Experimental group

Description:

White light bronchoscopy and autofluorescence bronchoscopy were carried out for people at high risk for lung cancer with heavy smoking (smoking history\> 400 years).Biopsy was taken for abnormal bronchial mucosa.

Treatment:

Procedure: white light bronchoscopy & autofluorescence bronchoscopy