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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02277366
• Other study ID #: lungcancer screening
• Secondary ID: 201402024-BS
• Status: Terminated
• Phase: N/A
• First received: October 21, 2014
• Last updated: November 13, 2015
• Start date: May 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Tang-Du Hospital	Changhai Hospital, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd., The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Erratum in: J Thorac Oncol. 2009 Apr;4(4):558. Gazdar, Adi [added]. — View Citation

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of all examinations to make a diagnosis		2 weeks	No
Primary	Diagnostic yield of Lung Cancer		1 week	No
Secondary	Number of Participants with Serious Adverse Events		1 week	No