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Evaluating the Pulmonary Nodule With Imaging and Biomarkers

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Olympus Ultrathin Bronchofibervideoscope (XP260F)
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Exhaled breath condensate (EBC) method, Volatile Organic Compounds (VOCs), Endobronchial Ultrasound (EBUS), Confocal Endoscopy, Exhaled alveolar gas

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.

Exclusion Criteria:

  • Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.

Sites / Locations

  • National University Hospital/ National University of SingaporeRecruiting

Outcomes

Primary Outcome Measures

Correlating pathology between EBUS, confocal microendoscopy and VOC patterns to aid in characterising malignant and benign etiology.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2012
Last Updated
November 28, 2012
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01739881
Brief Title
Evaluating the Pulmonary Nodule With Imaging and Biomarkers
Official Title
Evaluating the Pulmonary Nodule With Imaging and Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to determine if there are defining EBUS and confocal endoscopy features as well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar gas VOC from patients with lung cancer will be compared against exhaled breath VOC for signature compounds that may complement CT in screening the population at risk.
Detailed Description
AIMS To improve diagnostic yield of pulmonary nodule or mass by using combined approach of navigation bronchoscopy and EBUS. To determine if characteristic features of EBUS and confocal microendoscopy exist as well as VOC patterns in alveolar and exhaled gas that can aid in discriminating malignant pulmonary nodule or mass from benign etiology by correlating with pathology. To identify VOC patterns specific for lung cancer by correlating VOC from directly sampled alveolar gas and exhaled breath with pathology. Exhaled breath VOC signature may complement CT in screening population at risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Exhaled breath condensate (EBC) method, Volatile Organic Compounds (VOCs), Endobronchial Ultrasound (EBUS), Confocal Endoscopy, Exhaled alveolar gas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Olympus Ultrathin Bronchofibervideoscope (XP260F)
Other Intervention Name(s)
Olympus Lucera Broncho Fibervideoscope (BF-XP260F)
Intervention Description
The bronchovideoscope will be used together with an assisted image-guided bronchoscopic navigation software system called LungPoint®, to view lungs in a real time 3D manner.
Primary Outcome Measure Information:
Title
Correlating pathology between EBUS, confocal microendoscopy and VOC patterns to aid in characterising malignant and benign etiology.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses. Exclusion Criteria: Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pyng Lee, MD
Phone
+65-67795555
Email
mdclp@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pyng Lee, MD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital/ National University of Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pyng Lee, MD
Phone
+65-67795555
Email
mdclp@nus.edu.sg

12. IPD Sharing Statement

Citations:
PubMed Identifier
20610543
Citation
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Results Reference
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PubMed Identifier
20661089
Citation
Lee P, Colt HG. Bronchoscopy in lung cancer: appraisal of current technology and for the future. J Thorac Oncol. 2010 Aug;5(8):1290-300. doi: 10.1097/JTO.0b013e3181e41843.
Results Reference
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PubMed Identifier
12527571
Citation
Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.
Results Reference
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PubMed Identifier
15364779
Citation
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Results Reference
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PubMed Identifier
12412691
Citation
Herth FJ, Ernst A, Becker HD. Endobronchial ultrasound-guided transbronchial lung biopsy in solitary pulmonary nodules and peripheral lesions. Eur Respir J. 2002 Oct;20(4):972-4. doi: 10.1183/09031936.02.00032001.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Evaluating the Pulmonary Nodule With Imaging and Biomarkers

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