Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341387
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-18
Brief Title:
Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Volatolomic and Proteomic Profile Breath Urine and Serum as Non-invasive Tools for Early Diagnosis of Lung Cancer
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GCIMS 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
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 GCIMS 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 evaluationWe will conduct the trial according to the ICH Good Clinical Practice GCP guidelines Keeping accurate and consistent records is essential to a cooperative studyThe IEO Data Management Office will responsible of the study database and data management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None