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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Roberto Gasparri, MD, PhD
- Phone Number: 0257489499
- Email: roberto.gasparri@ieo.it
Study Locations
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Milan, Italy, 20141
- Recruiting
- Europen insitute of Oncology- Division of Thoracic Surgery
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Contact:
- Roberto Gasparri, MD, PhD
- Phone Number: 0257489499
- Email: roberto.gasparri@ieo.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Lung cancer group
- Diagnosis of early stage - lung cancer
- Signed Informed Consent
- Completed questionnaire
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Lung cancer patients
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
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breath sampling: all subjects exhale into two sterile Tedlar bags, connected to a mouthpiece, in a condition similar to traditional spirometry. Urine will be collected usual urine container. The blood sample (~ 5 ml) will be taken with a serum separator tube. |
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High Risk-Healthy Subjects
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
|
breath sampling: all subjects exhale into two sterile Tedlar bags, connected to a mouthpiece, in a condition similar to traditional spirometry. Urine will be collected usual urine container. The blood sample (~ 5 ml) will be taken with a serum separator tube. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk.
Time Frame: 12 months
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Enrolling two cohorts at baseline: healthy individuals at high risk with negative LDCT (no suspicious oncological findings) vs. patients with early-stage I/II lung cancer candidates for surgical resection; sampling in lung cancer patients will be performed pre-intervention.
We will assess and compare the serum and urinary proteomic and volatile organic compound profiles, serum and respiratory, of the two cohorts under study at baseline and changes in proteomic and volatile organic compound signature at 12 months from baseline.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Omics-Data intagration.
Time Frame: 6 months
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The serum proteomic and serum volatomomic, urinary, and respiratory data will be compared using algorithms based on artificial intelligence and deep learning.
Data from each test, including patient follow-up, will be analyzed using multivariate statistical analysis of samples with multivariable logistic and Cox proportional hazards regression models to identify the most significant variables.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R178522-ieo1906
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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