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Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Lung cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Current or ex-smokers who have smoked at least 20-pack-years (e.g. 1 pack per day for 20 years or more)
  • Informed consent

Exclusion Criteria:

  • Known malignant disease
  • Unstable major medical disease
  • Bleeding disorder
  • Unwilling to have a bronchoscopy
  • Women currently pregnant or nursing
  • Known reaction to xylocaine, a local anaesthesia agent used for bronchoscopy

Sites / Locations

  • Queen Mary Hospital

Outcomes

Primary Outcome Measures

Number of early stage lung cancer/precancerous lesion detected

Secondary Outcome Measures

Full Information

First Posted
November 21, 2007
Last Updated
October 22, 2013
Sponsor
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00563420
Brief Title
Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer
Official Title
Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong

4. Oversight

5. Study Description

Brief Summary
Lung cancer is the commonest malignant disease with a 5-year survival of 14%. In Hong Kong, it accounts for about 30% of all cancer death. The poor prognosis of lung cancer is due largely to the late clinical presentation of the disease. In order to improve the prognosis of lung cancer, an obvious approach is to develop sensitive methods for detecting lung cancer at much earlier stages when treatment is more likely to be curative. However, the best way for identifying early lung cancer is still need to be determined. We hypothesis that by examining specimens that contain shed bronchial epithelial cells i.e. sputum, lung cancer can be sampled in its earliest possible phase. And by using autofluorescence bronchoscopy, a system specifically designed to detect early lung cancer/pre-invasive lesions, to identify the source of abnormal cells, we may able to detect eraly lung cancer and followed by curative treatment to improve the prognosis of this disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Primary Outcome Measure Information:
Title
Number of early stage lung cancer/precancerous lesion detected
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Eligibility Criteria
Inclusion Criteria: Current or ex-smokers who have smoked at least 20-pack-years (e.g. 1 pack per day for 20 years or more) Informed consent Exclusion Criteria: Known malignant disease Unstable major medical disease Bleeding disorder Unwilling to have a bronchoscopy Women currently pregnant or nursing Known reaction to xylocaine, a local anaesthesia agent used for bronchoscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Lam, Dr
Organizational Affiliation
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer

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