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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563420
• Other study ID #: EC 1621-01
• Secondary ID: HARECCTR0500035
• Status: Completed
• Phase: N/A
• First received: November 21, 2007
• Last updated: October 22, 2013
• Start date: November 2002
• Est. completion date: June 2007

Study information

• Verified date: October 2013
• Source: Hospital Authority, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2007
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Procedure:
• Bronchoscopy

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of early stage lung cancer/precancerous lesion detected		Two years

External Links

•   HAREC Clinical Trial Registry