跳至主要内容
临床试验/NCT01660087
NCT01660087撤回不适用

Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device.

National University Hospital, Singapore4 个研究点 分布在 1 个国家开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验