Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer
NCT ID: NCT06341387
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2023-05-05
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Breathomics: May it Become an Affordable, New Tool for Early Diagnosis and Screening of Lung Cancer?
NCT06034730
Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohor
NCT06076005
A Study Developing a Non-invasive Urine-based Proteomic Model for Early Lung Cancer Detection.
NCT06733311
Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer
NCT07042867
Using Urine Samples to Identify Lung Cancer
NCT06033248
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Rome Tor Vergata
OTHER
European Institute of Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Europen insitute of Oncology- Division of Thoracic Surgery
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R178522-ieo1906
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.