Clinical trial · Observational
The Contribution of Induced Glycolysis to the Exhaled Volatile Organic Compounds' (VOCs) Signature in Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Lung cancer patients, pre treatment
- description
- Patients who have diagnosed with lung cancer before treatment
- label
- High risk patients for lung cancer
- description
- high risk patients who are age and co-morbidity matched controls without proof of lung cancer.
Primary outcomes (1)
- measure
- Diagnostic VOC signature for lung cancer
- timeFrame
- 2 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * individuals who suffer from diabetes * Individuals who suffer from lung cancer, and are currently being treated * minors ( under the age of 18)
References
Publications (0)
Data not yet available