Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device
This trial is active, not recruiting.
|Treatment||biophotonic platform for voc detection|
|Sponsor||National University Hospital, Singapore|
|Start date||April 2012|
|End date||March 2014|
|Trial size||80 participants|
|Trial identifier||NCT01660087, SERC/1121480001|
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
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||single group assignment|
Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.
Male or female participants at least 21 years old.
- All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.
- 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.
|Official title||Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device.|
|Principal investigator||Pyng Lee, MD|
|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.|
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