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Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer

NCT06341387 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-04-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    collaborator OTHER

  • European Institute of Oncology

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2024-05-30
Completion
2024-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06341387 on ClinicalTrials.gov