Bronchoscopy Screening for High-risk Population of Lung Cancer With Severe Smoking With Negative LDCT Screen
- Conditions
- Heavy Smoking
- Interventions
- Procedure: white light bronchoscopy & autofluorescence bronchoscopy
- Registration Number
- NCT04413669
- Lead Sponsor
- Jiayuan Sun
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Age 45-75 years;
- have a smoking history of ≥20 pack years; if participants quit smoking, it should be <15 years;
- Chest LDCT examination within one and a half years without obvious abnormalities or calcified nodules or non-calcified nodules and no signs of malignancy
- Non-smokers or mild smokers;
- There are contraindications to bronchoscopy, such as active hemoptysis, unstable angina pectoris, coagulation dysfunction, anesthesia allergy, etc .;
- Refusing to sign informed consent;
- The operator believes that the patient has other conditions that are not suitable for bronchoscopy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description white light bronchoscopy and autofluorescence bronchoscopy white light bronchoscopy & autofluorescence bronchoscopy 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.
- Primary Outcome Measures
Name Time Method 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. one year ALB and WLB were screened for LDCT screening for lung cancer negative severe smokers. The effect of AFB and WLB screening on LDCT screening negative lung cancer at high risk was analyzed.
- Secondary Outcome Measures
Name Time Method The diagnostic efficacy of WLB and AFB in lung cancer was compared one year The diagnostic efficacy of WLB and AFB in lung cancer was compared by comparing abnormalities under WLB and AFB and histopathology respectively.
Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer. one year Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.
RGB（red-green-blue） chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed. one year RGB（red-green-blue） chrominance spatial differences of AFB in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.
The independent risk factors of lung cancer in high-risk groups were Identified. one year Univariate and multivariate Logistic regression analysis was carried out to screen the independent risk factors of lung cancer in high-risk groups.
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China