Status:
TERMINATED
Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-75 years
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 purp...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
- Patient has pulmonary lesions suspected to be cancer from CT images.
- Female patient of childbearing potential has a positive result from a pregnancy test.
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02277366
Start Date
May 1 2015
End Date
November 1 2017
Last Update
November 16 2015
Active Locations (1)
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1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038