Clinical trial · Observational
Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer
Volatolomic and Proteomic Profile; Breath, Urine and Serum as Non-invasive Tools for Early Diagnosis of 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)
The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are: * Which are the "omics" biomarkers that characterize the early stage of lung cancer? * How to Translate Laboratory Data into Clinical Data? For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile.
Conditions
Conditions (4)
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 |
| Lung Cancer Diagnosis | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breath, urine and blood analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lung cancer patients
- description
- Age 50-80 years Diagnosis of early stage of lung cancer 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 Signed Informed Consent Completed questionnaire
- interventionNames
- Other: Breath, urine and blood analysis
- label
- High Risk-Healthy Subjects
- description
- Age 50-80 years 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 No previous malignancies within last 5 years No patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study Signed Informed Consent Completed questionnaire
- interventionNames
- Other: Breath, urine and blood analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available