Volatolomic and Proteomic Profile; Breath, Urine and Serum as Non-invasive Tools for Early Diagnosis of Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Europen insitute of Oncology- Division of Thoracic Surgery
RECRUITING
Milan
Contact Information
Primary
Roberto Gasparri, MD, PhD
roberto.gasparri@ieo.it
0257489499
Time Frame
Start Date: 2023-05-05
Estimated Completion Date: 2024-07-31
Participants
Target number of participants: 200
Treatments
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
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
Sponsors
Collaborators: University of Rome Tor Vergata
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov