Clinical trial NCT04413669: Bronchoscopy Screening for High-risk Population of Lung Cancer With Severe Smoking With Negative LDCT Screen
Official title: Bronchoscopy Screening of High-risk Population of Lung Cancer With Severe Smoking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heavy Smoking
Keywords: Heavy smoking
People at high risk for lung cancer
autofluorescence bronchoscopy，AFB
white light bronchoscopy, WLB
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of AFB and WLB screening （the positive rate of lung cancer）on LDCT screening negative at high risk for lung cancer was analyzed.
timeFrame: one year
Secondary outcomes:
measure: The diagnostic efficacy of WLB and AFB in lung cancer was compared
timeFrame: one year
measure: The independent risk factors of lung cancer in high-risk groups were Identified.
timeFrame: one year
measure: RGB（red-green-blue） chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.
timeFrame: one year
measure: Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, PhD
role: STUDY_DIRECTOR
References: