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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04413669
Enrollment
400
Registered
2020-06-04
Start date
2019-12-26
Completion date
2020-12-01
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Smoking

Keywords

Heavy smoking, People at high risk for lung cancer, autofluorescence bronchoscopy,AFB, white light bronchoscopy, WLB

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.

Interventions

PROCEDUREwhite light bronchoscopy & autofluorescence bronchoscopy

White light bronchoscopy and autofluorescence bronchoscopy were carried out,and Take a biopsy for abnormal bronchial mucosa

Sponsors

Jiayuan Sun
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 yearALB 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

MeasureTime frameDescription
The diagnostic efficacy of WLB and AFB in lung cancer was comparedone yearThe 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.one yearUnivariate 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.one yearRGB(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.one yearBlood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.

Countries

China

Contacts

Primary ContactJiayuan Sun, PhD
jysun1976@163.com86-021-22200000
Backup ContactJiayuan Sun, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026