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Trial record 15 of 87 for:    lung cancer AND risk factors

Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population

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ClinicalTrials.gov Identifier: NCT02277366
Recruitment Status : Terminated (We have recruited some patients, but we haven't found any significant result by bronchoscopy in the high risk population.)
First Posted : October 29, 2014
Last Update Posted : November 16, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Lung Neoplasms Procedure: Fluorescence Bronchoscopy/Narrow Band Bronchoscopy

Study Design

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
Study Start Date : May 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Fluorescence/Narrow Band Bronchoscopy
All patients in the group are examined by Fluorescence Bronchoscopy and Narrow Band Bronchoscopy to make a early detection of lung cancer.
Procedure: Fluorescence Bronchoscopy/Narrow Band Bronchoscopy
Fluorescence Bronchoscopy and Narrow Band Bronchoscopy are used in the Fluorescence/Narrow Band Bronchoscopy group to make a diagnosis of lung cancer.
Routine Bronchoscopy
All patients in this group are examined by routine bronchoscopy to make a early detection of lung cancer.


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic yield of Lung Cancer [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Number of Participants with Serious Adverse Events [ Time Frame: 1 week ]

Other Outcome Measures:
  1. Cost of all examinations to make a diagnosis [ Time Frame: 2 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All the patients recruited in the study should meet one item as follows.

  • 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.
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.
  • 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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277366


Locations
China, Shaanxi
Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
Xinqiao Hospital of Chongqing
China Meitan General Hospital
Micro-Tech (Nanjing) Co., Ltd.
Investigators
Principal Investigator: Faguang Jin, Ph.D, MD Tang-Du Hospital
More Information

Publications:
Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02277366     History of Changes
Other Study ID Numbers: lungcancer screening
201402024-BS ( Other Grant/Funding Number: Ministry of Health in China )
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Tang-Du Hospital:
Lung Neoplasms
Bronchoscopy
Early Detection of Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases