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

Heavy Smoking Clinical Trial

Official title:

Bronchoscopy Screening of High-risk Population of Lung Cancer With Severe Smoking

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413669
• Other study ID #: SHCHE201907
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, PhD
• Phone: 86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heavy Smoking
• Lung Neoplasms

Intervention

Procedure:
• white light bronchoscopy & autofluorescence bronchoscopy
White light bronchoscopy and autofluorescence bronchoscopy were carried out,and Take a biopsy for abnormal bronchial mucosa

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiayuan Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	one year
Secondary	The diagnostic efficacy of WLB and AFB in lung cancer was compared	The diagnostic efficacy of WLB and AFB in lung cancer was compared by comparing abnormalities under WLB and AFB and histopathology respectively.	one year
Secondary	The independent risk factors of lung cancer in high-risk groups were Identified.	Univariate and multivariate Logistic regression analysis was carried out to screen the independent risk factors of lung cancer in high-risk groups.	one year
Secondary	RGB(red-green-blue) chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.	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.	one year
Secondary	Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.	Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.	one year