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

October 22, 2013 updated by: Hospital Authority, Hong Kong

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.

Study Overview

Status

Completed

Conditions

Lung Neoplasms

Intervention / Treatment

Procedure: Bronchoscopy

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hong Kong, China
    - Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of early stage lung cancer/precancerous lesion detected Time Frame: Two years	Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

Principal Investigator: Bing Lam, Dr, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

HAREC Clinical Trial Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria