Back to resultsBronchoscopy Screening for High-risk Population of Lung Cancer With Severe Smoking With Negative LDCT Screen
Primary Purpose
Heavy Smoking
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
white light bronchoscopy & autofluorescence bronchoscopy
Sponsored by
About this trial
This is an interventional screening trial for Heavy Smoking focused on measuring Heavy smoking, People at high risk for lung cancer, autofluorescence bronchoscopy，AFB, white light bronchoscopy, WLB
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
white light bronchoscopy and autofluorescence bronchoscopy
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04413669
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiayuan Sun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Smoking
Keywords
Heavy smoking, People at high risk for lung cancer, autofluorescence bronchoscopy，AFB, white light bronchoscopy, WLB
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
white light bronchoscopy and autofluorescence bronchoscopy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
white light bronchoscopy & autofluorescence bronchoscopy
Intervention Description
White light bronchoscopy and autofluorescence bronchoscopy were carried out，and Take a biopsy for abnormal bronchial mucosa
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The diagnostic efficacy of WLB and AFB in lung cancer was compared
Description
The diagnostic efficacy of WLB and AFB in lung cancer was compared by comparing abnormalities under WLB and AFB and histopathology respectively.
Time Frame
one year
Title
The independent risk factors of lung cancer in high-risk groups were Identified.
Description
Univariate and multivariate Logistic regression analysis was carried out to screen the independent risk factors of lung cancer in high-risk groups.
Time Frame
one year
Title
RGB（red-green-blue） chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.
Description
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.
Time Frame
one year
Title
Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.
Description
Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, PhD
Phone
86-021-22200000
Ext
1511
Email
jysun1976@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayuan Sun, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, PhD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, PhD
Phone
+86-021-22200000
Ext
1511
Email
jysun1976@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Bronchoscopy Screening for High-risk Population of Lung Cancer With Severe Smoking With Negative LDCT Screen
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