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: Recruiting
• Conditions: Lung Cancer; Non-small Cell Lung Cancer Stage I; Non-small Cell Lung Cancer Stage II; Lung Cancer Diagnosis
• Intervention / Treatment: Other: Breath, urine and blood analysis

Detailed Description

All partecipants will sign the Informed Consent before the sampling procedures. In addition, they will complete the clinical questionnaire containing medical history, smoking history and psychological evaluation.We will conduct the trial according to the ICH Good Clinical Practice (GCP) guidelines. Keeping accurate and consistent records is essential to a cooperative study.The IEO Data Management Office will responsible of the study database and data management.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Roberto Gasparri, MD, PhD; Phone Number: 0257489499; Email: roberto.gasparri@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Europen insitute of Oncology- Division of Thoracic Surgery
    • Contact: Roberto Gasparri, MD, PhD; Phone Number: 0257489499; Email: roberto.gasparri@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Our experimental design consists to submit two groups of participants: Group1: 100 lung cancer patients scheduled for surgery resection of lung cancer. Group2: 100 high-risk healthy controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Breath, urine and blood analysis; 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.
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	Other: Breath, urine and blood analysis; 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
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.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Omics-Data intagration.	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.	6 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Collaborators: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lung cancer; Biomarkers; early diagnosis; Proteomic; Volatomic
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Disease
• Other Study ID Numbers: R178522-ieo1906

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No