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

NCT02277366 | Terminated DMC

• 2 other identifiers: lungcancer screening201402024-BS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

Lung Neoplasms; Bronchoscopy; Early Detection of Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of Lung Cancer

  1 week

Secondary Outcomes (1)

• Number of Participants with Serious Adverse Events

  1 week

Other Outcomes (1)

• Cost of all examinations to make a diagnosis

  2 weeks

Study Arms (2)

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

Routine Bronchoscopy

All patients in this group are examined by routine bronchoscopy to make a early detection of lung cancer.

Interventions

Fluorescence Bronchoscopy/Narrow Band Bronchoscopy PROCEDURE

Fluorescence Bronchoscopy and Narrow Band Bronchoscopy are used in the Fluorescence/Narrow Band Bronchoscopy group to make a diagnosis of lung cancer.

Fluorescence/Narrow Band Bronchoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead
• Changhai Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• China Meitan General Hospital: collaborator
• Micro-Tech (Nanjing) Co., Ltd.: collaborator

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

Related Publications (5)

• 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.

  PMID: 19356663 BACKGROUND

• 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.

  PMID: 21372486 BACKGROUND

• 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.

  PMID: 19096306 BACKGROUND

• 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.

  PMID: 18493485 BACKGROUND

• 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.

  PMID: 18060444 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Faguang Jin, Ph.D, MD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 29, 2014
• Study Start: May 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

CN (1)