Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer

NCT06341387 | Unknown

• 1 other identifier: R178522-ieo1906
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Omics-Data intagration.

  6 months

Study Arms (2)

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

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

Interventions

Breath, urine and blood analysis OTHER

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; Lung cancer patients

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead
• University of Rome Tor Vergata: collaborator

Study Sites (1)

Europen insitute of Oncology- Division of Thoracic Surgery

Milan, 20141, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples urine samples exhaled breath samples

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Disease

Interventions

Urination; Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Roberto Gasparri, MD, PhD

CONTACT

0257489499; roberto.gasparri@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 2, 2024
• Study Start: May 5, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2023-10

Locations

IT (1)