Clinical trial NCT01660087: Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device
Official title: Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Keywords: Exhaled breath condensate (EBC) method
Volatile Organic Compounds (VOCs)
Endobronchial Ultrasound (EBUS)
Confocal Endoscopy
Exhaled alveolar gas
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective of this proposal is to develop a non-invasive, inexpensive and accurate device that detects VOCs in exhaled breath for lung cancer screening. Toward this goal, the team will design and fabricate a biophotonic platform consists of arrays of silicon micro-ring resonator sensors coated with polymers with different organic functionalities, in which each sensor is widely responsive to a variety of VOCs for the detection of lung cancer by means of breath testing. The team will identify signature VOCs as lung cancer biomarkers by comparison VOC contents between alveolar gas that directly sampled from the nodule or mass and exhaled breath using gas chromatography/ mass spectrometry.

The specific aims of this proposal are as followings:

Aim 1: To develop a biophotonic platform for the detection of VOCs

Aim 2: To achieve multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device.

Aim 3: To evaluate the device as a lung cancer screening tool by testing both healthy and lung cancer breath samples

Detailed description: Lung cancer is the leading cause of cancer deaths throughout the world and accounts for more than 1.2M new cases worldwide annually, making lung cancer one of the most serious public health problems in industrialized countries. Up to date there is no valid screening method for lung cancer. Thus it is often diagnosed at an advance stage when treatment is less effective, which consequantly leads to high mortality rate. However, with early diagnosis and treatment, the 5-year survival rate improves dramatically from 1% in stage 4, 20% in stage 3 to 70% in stage 1 disease. Therefore early diagnosis plays a pivotal role in improving survival for this otherwise uniformly fatal disease. In recently studies, it was found that some of the products of metabolism, called volatile organic comounds (VOCs), are carried in the breath and can serve as biomarkers. Cancer cells produce different types of VOCs than normal cells do. More importantly, these VOC markers can be found in exhaled breath for cancer stages 1 through 4.

Combining the strength of IME's in the biophotonics, the research groups at NUS in basic science and the NUH clinician's knowledge and expertise in lung cancer, this proposal is aiming to tackle the challenge of lung cancer screening by developing a non-invasive, inexpensive, and accurate sensor platform to detect VOCs in exhaled breath. The device will consists of arrays of silicon micro-ring resonator sensors coated with polymers with different organic functionalities, in which each sensor is widely responsive to a variety of VOCs. In this proposal, we plan to build a prototype device and test for the detection of VOCs in exhaled breath from healthy controls and lung cancer patients. The successful outcome of this proposal would have an immense impact on lung cancer management by enabling an early stage cancer screening.

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.

Primary outcomes:
measure: Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Institute of Microelectronics
city: Singapore
country: Singapore
facility: National University Hospital/ National University of Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Pyng Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Microelectronics
name: Mi Kyoung Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
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