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Clinical Trials/NCT04413669
NCT04413669
Unknown
Not Applicable

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

Jiayuan Sun1 site in 1 country400 target enrollmentDecember 26, 2019
ConditionsHeavy Smoking

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heavy Smoking
Sponsor
Jiayuan Sun
Enrollment
400
Locations
1
Primary Endpoint
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.
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 26, 2019
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jiayuan Sun
Responsible Party
Sponsor Investigator
Principal Investigator

Jiayuan Sun

Director, Department of Endoscopy, Shanghai Chest Hospital

Shanghai Chest Hospital

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.

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

  • The diagnostic efficacy of WLB and AFB in lung cancer was compared(one year)
  • Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.(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.(one year)
  • The independent risk factors of lung cancer in high-risk groups were Identified.(one year)

Study Sites (1)

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