Clinical trial NCT06341387: Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer
Official title: Volatolomic and Proteomic Profile; Breath, Urine and Serum as Non-invasive Tools for Early Diagnosis of Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Non-small Cell Lung Cancer Stage I
Non-small Cell Lung Cancer Stage II
Lung Cancer Diagnosis
Keywords: Lung cancer
early diagnosis
Biomarkers
Proteomic
Volatomic
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: University of Rome Tor Vergata
First posted: 2024-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Omics-Data intagration.
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Europen insitute of Oncology- Division of Thoracic Surgery
Study officials:
References: