Analysis of Volatile Organic Compounds in Expired Air in Healthy Volunteers: Comparison of Three Mass Spectrometry Techniques for the Characterization of Volatolome in Clinical Studies

NCT06020521 | Completed

• 1 other identifier: 2023_0020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A major obstacle in precision medicine is the unavailability of biomarkers that are easy to access, non-invasive, measurable with high-performance techniques, fast, easy to use, reproducible, inexpensive and easily deployable on a large scale. The analysis of exhaled air (volatolomics) is an "omics" approach devoted to the analysis of volatile organic compounds (VOCs) eliminated by the pulmonary route with real-time detection, at the patient's bedside. The reference technology for the analysis of VOCs is mass spectrometry (MS). Several types of mass spectrometers can be used, and, in the absence of a consensual and standardized method, have practical methods for carrying out different analyzes which also lead to the generation of specific signals whose nature, complexity and exhaustiveness of information generated are heterogeneous. The clinical studies carried out to date use one of the analytical techniques available, without the choice necessarily being guided by objective factors. The objective of this study is to fill this gap and compare the information obtained by three mass spectrometry techniques available to our team (proton transfer reaction - mass spectrometry (PTR-MS), Soft Ionization by Chemical Reaction in Transfer (SICRIT) , two-dimensional gas chromatography-mass spectrometry (GCxGC-MS)) for volatolome analysis. The comparative analysis of the different signals will make it possible to determine the interests and limits of each technique and thus to direct preferentially towards one, the other, or combinations of them for the realization of future clinical studies. One of the main challenges also consists in establishing the concordance of the signals generated by the different technological approaches, some employing prior chromatographic separation, others not, and some employing soft ionization methods while those of others are on the contrary hard. Thus, the availability of datasets obtained on the same population with these complementary approaches will allow significant progress for the identification of the COVs of interest in clinical studies, beyond the simple comparison of the analytical performances of the different methods.

Conditions

Respiratory Disease

Keywords

precision medicine,; biomarkers; analysis of exhaled air (volatolomics); mass spectrometry

Outcome Measures

Primary Outcomes (1)

• To compare informations obtained by three different spectrometry techniques

  Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies

  one day

Secondary Outcomes (3)

• 1- Compare sampling techniques

  one day

• 2-Compare the profile of VOCs

  one day

• Determine the average time needed to perform each type of sample and associated analyzes

  one day

Study Arms (1)

Group of healthy volunteers

OTHER

This research will take place at the hospital and at the UFR Simone Veil-Santé with single sessions on the same day of approximately 10 minutes and 1 hour respectively. A list of healthy volunteers has already been established at the faculty. A provisional schedule for passing the various examinations provided for in the protocol is also scheduled. The experiments conducted at the UFR Simone Veil - Santé will take place within the Department of Health Biotechnology. This Department already has all the resources necessary for the successful completion of the study, in particular within the mass spectrometry platform which has the instruments (high resolution mass spectrometer Q-Exactive) and human resources (2 analytical science engineers, 1 data science engineer + technical staff and interns) required.

Other: Three spectrometry differents technics

Interventions

Three spectrometry differents technics OTHER

Collection of expired air as follows: * For online mass spectrometry techniques (PTR-MS and SICRIT) * For offline mass spectrometry (GCxGC-MS) Performing volatolome analyses: * By PTR-TOF-MS (Ionicon) and SICRIT-HRMS (SICRIT module (Plasmion) coupled to a Q-exactive instrument (Thermofisher)) for online analyzes * By two-dimensional gas chromatography coupled with mass spectrometry (Pegasus BT-4D, Leco) for the desorption tubes.

Group of healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteer
• At least 18 years old
• Perfect command of the French language
• Signature of an informed consent form
• Affiliated to a health insurance plan

You may not qualify if:

• Pregnant women
• People with known pathology(ies)
• Active smoking
• Deprived of liberty or under guardianship

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Grassin delyle

Suresnes, Suresnes, 92150, France

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research will take place at the hospital and at the UFR Simone Veil-Santé with single sessions on the same day of approximately 10 minutes and 1 hour respectively. A list of healthy volunteers has already been established at the faculty. A provisional schedule for passing the various examinations provided for in the protocol is also scheduled. The experiments conducted at the UFR Simone Veil - Santé will take place within the Department of Health Biotechnology. This Department already has all the resources necessary for the successful completion of the study, in particular within the mass spectrometry platform which has the instruments (high resolution mass spectrometer Q-Exactive) and human resources (2 analytical science engineers, 1 data science engineer + technical staff and interns) required.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: August 31, 2023
• Study Start: July 8, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

FR (1)