Identifying biomarkers for early lung cancer diagnosis
Volatolomic and Proteomic Profile; Breath, Urine and Serum as Non-invasive Tools for Early Diagnosis of Lung Cancer
This study is trying to find specific markers in breath, urine, and blood samples that can help detect early-stage lung cancer in patients compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06341387 on ClinicalTrials.gov |
What this trial studies
This observational study aims to discover specific biomarkers for early-stage lung cancer using non-invasive samples such as breath, urine, and serum from 200 participants, including 100 healthy controls and 100 lung cancer patients. Participants will provide samples before lung cancer resection, which will be analyzed using advanced techniques like eNose and Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS), as well as mass-spectrometry-based proteomics. The study seeks to identify omics biomarkers that can distinguish early-stage lung cancer from healthy individuals and translate laboratory findings into clinical applications.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with early-stage lung cancer and high-risk healthy individuals such as heavy smokers or those with a family history of lung cancer.
Not a fit: Patients with previous malignancies, those who have undergone chemotherapy or radiotherapy for lung cancer, or individuals with psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of lung cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using omics approaches for cancer diagnosis, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Lung cancer group * Diagnosis of early stage - lung cancer * Signed Informed Consent * Completed questionnaire 2. Healthy subjects * high risk individuals (heavy smokers, subjects with pulmonary disease non-cancer related or with a familiar history of lung cancer disease) * Recent (within 6 months) negative Chest X-ray or CT scan Exclusion Criteria: Both groups * No previous chemo or radiotherapy for lung cancer * No previous malignancies within last 5 years * No abuse of alcohol (no more than 1 litre of wine for day). * No patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Where this trial is running
Milan
- Europen insitute of Oncology- Division of Thoracic Surgery — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Roberto Gasparri, MD, PhD
- Email: roberto.gasparri@ieo.it
- Phone: 0257489499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.