A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population

Tang-Du Hospital1 site in 1 country400 target enrollmentMay 2015

ConditionsLung Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung Neoplasms
Sponsor: Tang-Du Hospital
Enrollment: 400
Locations: 1
Primary Endpoint: Diagnostic yield of Lung Cancer
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

November 2017

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Tang-Du Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400)
•Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes.
•The nature of cough changes in a patient who has chronic respiratory disease.
•Patient has blood-stained sputum persistently or repeatedly without obvious causes.
•Patient will be included if accorded with any item of above.

Exclusion Criteria

•Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
•Patient has uncontrollable hypertension (SBP \> 180mmHg).
•Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
•Patient has blood coagulation disorders (PT\>2 times the upper limit of normal(ULN) or Platelet(PLT)\<50000/ul）.
•Patient has severe dyspnea.
•Patient is allergic to local anesthetic.
•Patient is unable to provide informed consent.
•Patient is not an appropriate candidate for or is unable to tolerate flexible bronchoscopy procedures.
•Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
•Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.