The Contribution of Induced Glycolysis to the Exhaled Volatile Organic Compounds' (VOCs) Signature in Lung Cancer
1 other identifier
observational
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFebruary 21, 2014
February 1, 2014
1.6 years
April 8, 2013
February 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic VOC signature for lung cancer
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.
2 year
Study Arms (2)
Lung cancer patients, pre treatment
Patients who have diagnosed with lung cancer before treatment
High risk patients for lung cancer
high risk patients who are age and co-morbidity matched controls without proof of lung cancer.
Eligibility Criteria
The population will include a total of 70 participants, 50 of which currently suffer from lung cancer, and have not yet begun any form of medical treatment whilst the remaining group consists of 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.
You may qualify if:
- individuals who currently suffer from lung cancer, who have not yet begun any medical treatment
- 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
You may not qualify if:
- individuals who suffer from diabetes
- Individuals who suffer from lung cancer, and are currently being treated
- minors ( under the age of 18)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nir Peled, MD PhD FCCP
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Thoracic Cancer Research and Detection Center- MD PhD FCCP
Study Record Dates
First Submitted
April 8, 2013
First Posted
May 14, 2013
Study Start
September 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
February 21, 2014
Record last verified: 2014-02