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

NCT ID: NCT04413669

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-26
• Study Completion Date: 2020-12-01

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.

Conditions

Heavy Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

white light bronchoscopy & autofluorescence bronchoscopy

Intervention Type: PROCEDURE

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

Interventions

white light bronchoscopy & autofluorescence bronchoscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiayuan Sun

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Director, Department of Endoscopy, Shanghai Chest Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jiayuan Sun, PhD

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiayuan Sun, PhD

Role: CONTACT

jysun1976@163.com

86-021-22200000 ext. 1511

Jiayuan Sun, MD

Role: CONTACT

Facility Contacts

Jiayuan Sun, PhD

Role: primary

jysun1976@163.com

+86-021-22200000 ext. 1511

Other Identifiers

SHCHE201907

Identifier Type: -

Identifier Source: org_study_id