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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Neoplasms
• Intervention / Treatment: Procedure: Fluorescence Bronchoscopy/Narrow Band Bronchoscopy

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic yield of Lung Cancer	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Serious Adverse Events	1 week

Other Outcome Measures

Outcome Measure	Time Frame
Cost of all examinations to make a diagnosis	2 weeks

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: J Thorac Oncol. 2009 Apr;4(4):558. Gazdar, Adi [added].
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 26, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Bronchoscopy; Early Detection of Cancer; Lung Neoplasms
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: lungcancer screening; 201402024-BS (Other Grant/Funding Number: Ministry of Health in China)