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

• ClinicalTrials.gov Identifier: NCT02277366
• Recruitment Status: Terminated
• First Posted: October 29, 2014
• Last Update Posted: November 16, 2015
• 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.
• Information provided by (Responsible Party): Tang-Du Hospital

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

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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

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:

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. Review.

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.

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, Wagnières G. Autofluorescence bronchoscopy: quantification of inter-patient variations of fluorescence intensity. Lasers Med Sci. 2009 Jan;24(1):45-51. Epub 2007 Nov 30.

• Responsible Party: Tang-Du Hospital
• ClinicalTrials.gov Identifier: NCT02277366
• Other Study ID Numbers: lungcancer screening; 201402024-BS ( Other Grant/Funding Number: Ministry of Health in China )
• First Posted: October 29, 2014
• 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; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases