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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heavy Smoking
• Intervention / Treatment: Procedure: white light bronchoscopy & autofluorescence bronchoscopy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: white light bronchoscopy and 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.	Procedure: white light bronchoscopy & autofluorescence bronchoscopy; White light bronchoscopy and autofluorescence bronchoscopy were carried out，and Take a biopsy for abnormal bronchial mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Jiayuan Sun

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Heavy smoking; People at high risk for lung cancer; autofluorescence bronchoscopy，AFB; white light bronchoscopy, WLB
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SHCHE201907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No