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Status unknownNCT04413669Updated Jun 4, 2020

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

An interventional study of white light bronchoscopy & autofluorescence bronchoscopy in Heavy Smoking, sponsored by Jiayuan Sun. Status unknown at 1 site in China. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Jiayuan Sun · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Heavy Smoking

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Keywords

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

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 400 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Jiayuan Sun is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: white light bronchoscopy & autofluorescence bronchoscopy

Interventions

  • Procedurewhite light bronchoscopy & autofluorescence bronchoscopy

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

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What researchers measure

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.

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: one year

  2. 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.

    Time frame: one year

  3. 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.

    Time frame: one year

  4. 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.

    Time frame: one year

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Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, Shanghai 200030, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04413669
Lead sponsor
Jiayuan Sun
Responsible party
Jiayuan Sun (Director, Department of Endoscopy, Shanghai Chest Hospital, Shanghai Chest Hospital) — Sponsor-investigator
First posted
Jun 4, 2020
Start date
Dec 26, 2019
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Jun 4, 2020

Study contacts

Jiayuan Sun, PhD
Contact
jysun1976@163.com
86-021-22200000 ext. 1511
Jiayuan Sun, MD
Contact
Jiayuan Sun, PhD
study director · Shanghai Chest Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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