NCT00563420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

First QC Date

November 21, 2007

Last Update Submit

October 22, 2013

Conditions

Lung Neoplasms

Keywords

Lung cancer

Outcome Measures

Primary Outcomes (1)

  • Number of early stage lung cancer/precancerous lesion detected

    Two years

Interventions

BronchoscopyPROCEDURE

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Bing Lam, Dr

    Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

November 1, 2002

Study Completion

June 1, 2007

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

CN(1)