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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00563420
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 7.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms	Procedure: Bronchoscopy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Non-Randomized
• Primary Purpose: Diagnostic
• Official Title: Early Lung Cancer Detection in Patients With Sputum Cytology and Autofluorescence Bronchoscopy in People at High Risk of Lung Cancer
• Study Start Date: Nov 1, 2002
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Number of early stage lung cancer/precancerous lesion detected [Two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		China

Sponsors and Collaborators

• Hospital Authority, Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563420
• Other Study ID Numbers: EC 1621-01; HARECCTR0500035
• First Posted: Nov 26, 2007
• Last Update Posted: Oct 23, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by , ,: Lung cancer
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Oct 23, 2013