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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 (VOC-COMPARE)

Primary Purpose

Respiratory Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Three spectrometry differents technics
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Respiratory Disease focused on measuring precision medicine,, biomarkers, analysis of exhaled air (volatolomics), mass spectrometry

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Pregnant women People with known pathology(ies) Active smoking Deprived of liberty or under guardianship

Sites / Locations

  • Grassin delyleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Group of healthy volunteers

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1- Compare sampling techniques
Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies
2-Compare the profile of VOCs
Compare the profile of VOCs of differents patients
Determine the average time needed to perform each type of sample and associated analyzes
Determine the average time needed to perform each type of sample and associated analyzes

Full Information

First Posted
August 28, 2023
Last Updated
August 31, 2023
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT06020521
Brief Title
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
Acronym
VOC-COMPARE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Precision medicine, or personalized medicine or individualized medicine, represents an important source of hope for alleviating the social and economic burden of severe pathologies. There is no commonly accepted definition of the notion of "personalized medicine". However, according to the European Council, personalized medicine is a medical model that relies on the characterization of people's phenotypes and genotypes (e.g. through molecular profiling, medical imaging, lifestyle information) to offer the right therapeutic strategy to the right person at the right time and/or to establish the existence of a predisposition to a disease and/or to ensure targeted and timely prevention. Personalized medicine is linked to the broader notion of "patient-centred care", which takes into account the general need for health systems to better meet the needs of patients. Advances in research have made it possible to develop "omic" signatures of therapeutic responses to certain cancers or rare diseases. However, if a few omic or cellular biomarkers have been developed, they remain today insufficient and too complex to foresee their generalization for the individualized treatment of patients. Thus, today there is significant potential for the development of precision medicine for severe pathologies. 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 derived from the latest "omics" technology, metabolomics, devoted to the analysis of small molecules in the body, and allows real-time detection, sick bed, volatile organic compounds (VOCs) eliminated through the lungs. Thousands of VOCs have been identified in exhaled air following infectious, inflammatory or pathological events with examples in the field of infectious diseases for the diagnosis of tuberculosis, invasive fungal infections, bacterial colonization of the airways or ventilator-associated pneumonia in intensive care patients . For viral infections, animal models of influenza infections and clinical studies in patients with chronic obstructive pulmonary disease also suggest the benefit of VOC analysis . In this infectious context, the "respiratory fingerprint" detected reflects a mixture of metabolites of microbial origin, direct biomarkers of the presence of pathogenic agents, and metabolites generated by the host in response to the infection. Thus, the analysis of exhaled air, the main advantages of which are totally non-invasive sampling and the instantaneous analysis allowed by certain technologies (result in a few minutes) could be used for diagnosis, large-scale screening, surveillance of infections and prediction of response to treatment. The technological challenges for its realization are linked to the great chemical diversity of the VOCs to be studied and the particularly low abundance of many of them. The reference technology for the analysis of VOCs is mass spectrometry (MS), which uses instruments consisting of - an ionization source whose function is to ionize the VOCs contained in exhaled air, - an analyzer which sorts the ions formed according to their mass to charge ratio (m/z) and - a detector which allows the quantitative analysis of the m/z signals of a sample . 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 signals specific to each of them, the nature, the complexity and the completeness of the information contained being heterogeneous. Each type of instrument has advantages and disadvantages in terms of ease of sampling, speed of analysis, completeness of information and technical and analytical constraints for carrying out the analyses. For example, some instruments such as proton transfer reaction mass spectrometers (PTR-MS) or those using soft ionization by chemical transfer reaction (SICRIT) are relevant for perform measurements online and in real time, without storing a sample of exhaled air but vary by their mode of ionization and the resolution of the associated detectors. However, their level of information generated does not generally allow VOCs to be identified (soft ionization, absence of chromatographic separation, etc.). Indeed, once a signature of VOCs (characterized by their m/z) is discovered, their formal chemical identification is then the critical and obligatory step to improve knowledge on the physiology and regulatory processes of VOCs as well as to set up and clinically validate specific quantitative measurement methods based on portable technologies (sensors, etc.). Two-dimensional gas chromatography coupled with mass spectrometry (GCxGC-MS) is the most advanced technology at present for this purpose, combining two chromatographic columns with complementary stationary phases and ionization of VOCs by electron impact before MS detection. Compounds coeluting in conventional gas chromatography can be separated by GCxGC, and several teams have published proof-of-concept studies using GCxGC-MS for breath biomarker discovery for lung cancer diagnosis , tuberculosis or severe asthma phenotyping . One of the main challenges consists in establishing the concordance of the signals generated by the different technological approaches, some employing a preliminary chromatographic separation, others not, and some employing soft ionization methods whereas those of the others are on the contrary hard. Thus, the availability of datasets obtained on the same population with these complementary technological 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
Keywords
precision medicine,, biomarkers, analysis of exhaled air (volatolomics), mass spectrometry

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of healthy volunteers
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Three spectrometry differents technics
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare informations obtained by three different spectrometry techniques
Description
Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies
Time Frame
one day
Secondary Outcome Measure Information:
Title
1- Compare sampling techniques
Description
Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies
Time Frame
one day
Title
2-Compare the profile of VOCs
Description
Compare the profile of VOCs of differents patients
Time Frame
one day
Title
Determine the average time needed to perform each type of sample and associated analyzes
Description
Determine the average time needed to perform each type of sample and associated analyzes
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnant women People with known pathology(ies) Active smoking Deprived of liberty or under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanislas Grassin delyle, PR
Phone
01 46 25 73 93
Email
s.grassindelyle@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
DRCI promotion
Phone
01 46 25 36 42
Email
drci-promotion@hopital-foch.com
Facility Information:
Facility Name
Grassin delyle
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanislas Grassin delyle, PR
Phone
04 46 25 73 93
Email
s.grassindelyle@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
DRCI PROMOTION
Phone
01 46 25 36 42
Email
drci-promotion@hopital-foch.com

12. IPD Sharing Statement

Learn more about this trial

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

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