Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer

European Institute of Oncology

Status: Enrolling

Conditions: Non-small Cell Lung Cancer Stage II; Lung Cancer Diagnosis; Lung Cancer; Non-small Cell Lung Cancer Stage I

Treatments: Other: Breath, urine and blood analysis

Study type: Observational

Funder types: Other

Identifiers

NCT06341387

R178522-ieo1906

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

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

Treatment:

Other: Breath, urine and blood analysis

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

Treatment:

Other: Breath, urine and blood analysis