NCT06341387

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer Stage I
• Non-small Cell Lung Cancer Stage II
• Lung Cancer Diagnosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-05
• Primary completion: 2024-05-30
• Completion: 2024-07-31
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: Italy