Clinical trial NCT02277366: Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
Official title: A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Neoplasms
Keywords: Lung Neoplasms
Bronchoscopy
Early Detection of Cancer
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Xinqiao Hospital of Chongqing
name: China Meitan General Hospital
name: Micro-Tech (Nanjing) Co., Ltd.
First posted: 2014-10-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.
* 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.

Primary outcomes:
measure: Diagnostic yield of Lung Cancer
timeFrame: 1 week
Secondary outcomes:
measure: Number of Participants with Serious Adverse Events
timeFrame: 1 week
Other outcomes:
measure: Cost of all examinations to make a diagnosis
timeFrame: 2 weeks
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Faguang Jin, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moghissi K, Dixon K, Stringer MR. Current indications and future perspective of fluorescence bronchoscopy: a review study. Photodiagnosis Photodyn Ther. 2008 Dec;5(4):238-46. doi: 10.1016/j.pdpdt.2009.01.008. Epub 2009 Feb 23.
citation: Ali AH, Takizawa H, Kondo K, Nakagawa Y, Toba H, Khasag N, Kenzaki K, Sakiyama S, Mohammadien HA, Mokhtar EA, Tangoku A. Follow-up using fluorescence bronchoscopy for the patients with photodynamic therapy treated early lung cancer. J Med Invest. 2011 Feb;58(1-2):46-55. doi: 10.2152/jmi.58.46.
citation: Edell E, Lam S, Pass H, Miller YE, Sutedja T, Kennedy T, Loewen G, Keith RL, Gazdar A. Detection and localization of intraepithelial neoplasia and invasive carcinoma using fluorescence-reflectance bronchoscopy: an international, multicenter clinical trial. J Thorac Oncol. 2009 Jan;4(1):49-54. doi: 10.1097/JTO.0b013e3181914506.
citation: Venmans BJ, Van Boxem TJ, Smit EF, Postmus PE, Sutedja TG. Results of two years expenience with fluorescence bronchoscopy in detection of preinvasive bronchial neoplasia. Diagn Ther Endosc. 1999;5(2):77-84. doi: 10.1155/DTE.5.77.
citation: Gabrecht T, Lovisa B, van den Bergh H, Wagnieres G. Autofluorescence bronchoscopy: quantification of inter-patient variations of fluorescence intensity. Lasers Med Sci. 2009 Jan;24(1):45-51. doi: 10.1007/s10103-007-0518-y. Epub 2007 Nov 30.