The Contribution of Induced Glycolysis to the Exhaled Volatile Organic Compounds' (VOCs) Signature in Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Diagnostic VOC signature for lung cancer
研究概览
简要总结
Lung cancer is the most lethal cancer, killing ~1.3 million people worldwide every year. Early diagnosis could increase its survival by 3-4 folds. Therefore the yield of screening for lung cancer is not a question anymore and the urgent unmet need is to define the group that is under a high risk for lung cancer.
Our lab is focusing on revealing non-invasive biomarkers as for early detection of lung cancer. This study specifically focuses on biomarkers that are found in exhaled breath. These biomarkers are known as volatile organic compounds (VOCs).The VOCs' profile can discriminate between those who suffer from lung cancer and healthy individuals.
It is well established that a cancer cell can activate their glycolysis (glucose degradation) pathway in order to survive. This links malignant processes with this basic biochemical, metabolic cycle. This study will focus on the unique processes incurred by glycolysis in the tumor cells and its effect on the surrounding environment. By better understanding and revealing the exact mechanism, it will become possible to identify the biomarkers released by malignant cells that use glycolysis as a source of energy.
This study's goal is to identify and analyze those distinguishing VOCs. The hope is that these VOCs will provide a new innovative possibility of developing the so desperately needed, early-detection lung cancer screening method.
This research will collect and analyze the exhaled breath of participants. The exhaled breath will be obtained before and after a glucose challenge test, in which the participant is asked to drink a solution containing water and glucose. This study will involve a total of seventy participants, fifty of which currently suffer from active lung cancer, while the remaining participants belong to a high-risk group.
详细描述
The Contribution of induced Glycolysis to the Exhaled Volatile Organic Compounds' (VOCs) Signature in Lung Cancer
Abstract:
Lung cancer is infamous for its cruel mortality rates as it is the most lethal cancer in both men and women. Unfortunately, most lung cancers are detected and diagnosed at a very advanced stage and this complicates treatment options. Therefore, there is dire, unmet need to develop an effective, highly sensitive, highly specific and non-invasive screening method. The solution to this problem may be found in volatile organic compounds (VOCs) which are organic molecules identified in exhaled breath. These VOCs differ between those individuals who suffer from lung cancer and healthy individuals. Seeing as increased glycolysis is one of the characteristic patterns of malignancies, the purpose of this study is to determine the contribution of induced glycolysis to these exhaled VOCs. Therefore, this study will compare exhaled breath samples in individuals who suffer from lung cancer before and after a glucose challenge test. This study aims to better understand the mechanisms involved in order to identify the distinguishing VOCs. This may aid in developing the so necessary diagnostic means for lung cancer screening.
- Introduction:
Lung cancer is the moth lethal cancer in both men and women. [1] There are two main classes of lung cancer: the first, Small Cell Lung Cancer (SCLC) which is often referred to as Oat Cell Cancer, and the second being Non-Small Cell Lung Cancer (NSCLC), which constitutes the majority of cases of lung cancer. [2] Unfortunately, most lung cancer detection and diagnosis is performed when the cancer is in an advanced, metastatic stage in which surgery is not a viable treatment option. [3] Thus, detection and diagnosis its early stages may significantly improve the five year survival rate as well as provide the possibility of a cure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 individuals who currently suffer from lung cancer, who have not yet begun any medical treatment
- •20 individuals who have been defined as high-risk patients for lung cancer by the Research and Detection Unit for Thoracic malignancies at the Sheba Medical Center, Tel Hashomer, Israel
排除标准
- •individuals who suffer from diabetes
- •Individuals who suffer from lung cancer, and are currently being treated
- •minors ( under the age of 18)
结局指标
主要结局
Diagnostic VOC signature for lung cancer
时间窗: 2 year
Each breath sample will be analyzed to identify VOCs via the GC-MS and Artificaial olfactory System AOS. We expect a significant difference between the VOC template before and after the glucose challenge test. The estimated difference of effect \~ 30%, with a sampling error \~ 10% and CI \~ 95% and sample size of 20-25 persons. The information from the AOS which recorded the changes in resistance will be analyzed via PCA to focus on the specific VOC pattern changes obtained in each sample. The remaining variables which were measured quantitatively will be presented in averages with their corresponding standard deviations. Those variables that were obtained quantitatively will be presented as percentages. Statistical analysis for significance will be performed by the following statistical tests: Student's T Test, Chi-Square, Analysis of Variance (ANOVA), and the Kruskal-Wallis test.
次要结局
未报告次要终点
研究者
Dr. Nir Peled MD, PhD
Head, Thoracic Cancer Research and Detection Center- MD PhD FCCP
Sheba Medical Center