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

NCT04413669 | Unknown

• 1 other identifier: SHCHE201907
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Smoking

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The diagnostic efficacy of WLB and AFB in lung cancer was compared

  one year

• The independent risk factors of lung cancer in high-risk groups were Identified.

  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

• Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.

  one year

Study Arms (1)

white light bronchoscopy and autofluorescence bronchoscopy

EXPERIMENTAL

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

Interventions

white light bronchoscopy & autofluorescence bronchoscopy PROCEDURE

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

white light bronchoscopy and autofluorescence bronchoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiayuan Sun: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

• Jiayuan Sun, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, PhD

CONTACT

86-021-22200000; jysun1976@163.com

Jiayuan Sun, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Endoscopy, Shanghai Chest Hospital

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: June 4, 2020
• Study Start: December 26, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)