Oxidative InjuryNCT06372054
TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models
An observational study of Oxidative Injury and Stress Physiological, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight… Read more about this study
- Who is it for?
- Ages 26 to 38 years
- Conditions the study is for
- Oxidative Injury, Stress Physiological, Discogenic Pain
- What is being tested?
- Biological sample collection
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 5 Feb 2024to 5 Feb 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 38 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.
Who may be able to join
- Being part of the Italian Air Force, as in active flight service or ground staff
- Age between 26 and 38 years
- Consent to collect biological samples and use the wearable device to monitor exposure parameters
Who cannot join
- Age < 25 years and > 39 years
- no signature on informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy
Milan, 20139
Stefania E Navone, PhD, 0256660100 ext. +39, stefania.navone@policlinico.mi.it
Giovanni Marfia, MD, PhD
About this study
Official title: Integration of Omics-based Technologies and Artificial Intelligence to Identify Predictive Risk Models in a Air Force's Pilot Cohort for the Maintenance of Safety, Well-being, Health, and Performance to be Translated to Civil Population
The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine.
Read the detailed description
The high-performance pilots of the Italian Air Force are "super healthy" individuals subjected to particular working conditions, as changes in temperature, pressure, gravity, acceleration, exposure to cosmic rays and radiation, which determine psycho-physical adaptation mechanisms to maintain homeostasis. However, this environmental exposure may potentially affect human health, well-being and performance.
The study aims to collect exposure data, clinical, physiological data through biosensors and molecular parameters (at different time point), to be integrated by an Artificial Intelligence algorithm expressly trained to create reliable risk models.
The final outcome will consist of the identification of significant biomarkers of pathological risk, in order to better understand the etiopathological mechanisms of many human diseases and apply early and personalized countermeasures to maintain and empower workers' health status and performance, avoiding clinical symptom presentation.
- Conditions
- Oxidative Injury, Stress Physiological, Discogenic Pain, Cardiovascular Risk Factor, Space Maintenance, Epigenetic Changes
- Being tested
- Biological sample collection
- Keywords
- pilots, air force, epigenetic change, environmental exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Collection of biological samples (blood, urine, saliva) and clinical data
| Study group | Role | What they receive |
|---|---|---|
| High-performance Italian Air Force Pilots | The primary study cohort is represented by "super-healthy" high-performance Italian Air Force Pilots, aged between 26 and 38 years, in active flight service.
Intervention: not applicable Receives: Other: Biological sample collection | |
| Italian Air Force ground staff | This cohort of Italian Air Force ground personnel will be used as a control group to compare data from the pilot cohort. Receives: Other: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of flight-related exposure data and molecular modifications
Collection of information on: i) lifestyle, ii) medical examination, iii) previous trauma, iv) cumulative professional exposure to flying, determination of panel of genes and circulating markers to assess prognostic and predictive factors
Measured: Through study completion, an average of 3 year
Secondary outcomes (4)
Assessment of General Health
Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)
Measured: Through study completion, an average of 3 year
Assessment of Sleep Quality
Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)
Measured: Through study completion, an average of 3 year
Assessment of eating habits
Recording of eating habits by Food Frequency Questionnaire (EPIC)
Measured: Through study completion, an average of 3 year
Creation of reliable AI and disease-based models for personalized medicine
Integration of information obtained from anamnesis, questionnaires, biochemical, genomic, epigenomic, proteomic data with the measurement of heart rate, oxygenation, acceleration, external temperature, presence of ultrasound, infrasound and radiation with artificial intelligence algorithm for the creation of reliable models of disease based on personalized medicine
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start5 Feb 2024
- Primary completion5 Feb 2025 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oxidative InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Italian Air Force, A-Tono, Ministry of Defense, Italy
- Responsible party
- Sponsor
- Investigators
- Giovanni Marfia, MD, PhD, Principal investigator, Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air ForceEmanuele Garzia, MD, PhD, Study chair, Italian Air ForceMarco Locatelli, MD, PhD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoFrancesco Vestito, PhD, Study chair, Italian Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372054
- Sponsor's protocol ID
- TORNADO
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject's data will be collected in completely anonymized form.
Publications
Marfia G, Navone SE, Guarnaccia L, Campanella R, Locatelli M, Miozzo M, Perelli P, Della Morte G, Catamo L, Tondo P, Campanella C, Lucertini M, Ciniglio Appiani G, Landolfi A, Garzia E. Space flight and central nervous system: Friends or enemies? Challenges and opportunities for neuroscience and neuro-oncology. J Neurosci Res. 2022 Sep;100(9):1649-1663. doi: 10.1002/jnr.25066. Epub 2022 Jun 9.
PubMed 35678198Marfia G, Guarnaccia L, Navone SE, Ampollini A, Balsamo M, Benelli F, Gaudino C, Garzia E, Fratocchi C, Di Murro C, Ligarotti GK, Campanella C, Landolfi A, Perelli P, Locatelli M, Ciniglio Appiani G. Microgravity and the intervertebral disc: The impact of space conditions on the biomechanics of the spine. Front Physiol. 2023 Mar 14;14:1124991. doi: 10.3389/fphys.2023.1124991. eCollection 2023.
PubMed 36998982
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Omics-based Technologies and Artificial Intelligence to Identify Predictive Risk Models in a Air Force's Pilot Cohort for the Maintenance of Safety, Well-being, Health, and Performance to be Translated to Civil Population
- ClinicalTrials.gov ID
- NCT06372054
- Acronym / sponsor ID
- TORNADO
- Conditions
- Oxidative Injury, Stress Physiological, Discogenic Pain, Cardiovascular Risk Factor, Space Maintenance, Epigenetic Changes
- Keywords
- pilots, air force, epigenetic change, environmental exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Milan, Italian Air Force, A-Tono, Ministry of Defense, Italy
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine.
Detailed description
The high-performance pilots of the Italian Air Force are "super healthy" individuals subjected to particular working conditions, as changes in temperature, pressure, gravity, acceleration, exposure to cosmic rays and radiation, which determine psycho-physical adaptation mechanisms to maintain homeostasis. However, this environmental exposure may potentially affect human health, well-being and performance.
The study aims to collect exposure data, clinical, physiological data through biosensors and molecular parameters (at different time point), to be integrated by an Artificial Intelligence algorithm expressly trained to create reliable risk models.
The final outcome will consist of the identification of significant biomarkers of pathological risk, in order to better understand the etiopathological mechanisms of many human diseases and apply early and personalized countermeasures to maintain and empower workers' health status and performance, avoiding clinical symptom presentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-performance Italian Air Force Pilots | – | Other: Biological sample collectionThe primary study cohort is represented by "super-healthy" high-performance Italian Air Force Pilots, aged between 26 and 38 years, in active flight service. Intervention: not applicable |
| Italian Air Force ground staff | – | Other: Biological sample collectionThis cohort of Italian Air Force ground personnel will be used as a control group to compare data from the pilot cohort. |
Who may qualify
- Ages
- 26 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.
Key inclusion criteria (3 listed)
- Being part of the Italian Air Force, as in active flight service or ground staff
- Age between 26 and 38 years
- Consent to collect biological samples and use the wearable device to monitor exposure parameters
Key exclusion criteria (2 listed)
- Age < 25 years and > 39 years
- no signature on informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionCollection of biological samples (blood, urine, saliva) and clinical data | Other | High-performance Italian Air Force Pilots, Italian Air Force ground staff |
Primary outcome
Assessment of flight-related exposure data and molecular modifications
Time frame: Through study completion, an average of 3 year
Collection of information on: i) lifestyle, ii) medical examination, iii) previous trauma, iv) cumulative professional exposure to flying, determination of panel of genes and circulating markers to assess prognostic and predictive factors
4 secondary outcomes
Assessment of General Health
Time frame: Through study completion, an average of 3 year
Assessment of Sleep Quality
Time frame: Through study completion, an average of 3 year
Assessment of eating habits
Time frame: Through study completion, an average of 3 year
Creation of reliable AI and disease-based models for personalized medicine
Time frame: Through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Results publication: PubMed 35678198Marfia G, Navone SE, Guarnaccia L, Campanella R, Locatelli M, Miozzo M, Perelli P, Della Morte G, Catamo L, Tondo P, Campanella C, Lucertini M, Ciniglio Appiani G, Landolfi A, Garzia E. Space flight and central nervous system: Friends or enemies? Challenges and opportunities for neuroscience and neuro-oncology. J Neurosci Res. 2022 Sep;100(9):1649-1663. doi: 10.1002/jnr.25066. Epub 2022 Jun 9.
- Results publication: PubMed 36998982Marfia G, Guarnaccia L, Navone SE, Ampollini A, Balsamo M, Benelli F, Gaudino C, Garzia E, Fratocchi C, Di Murro C, Ligarotti GK, Campanella C, Landolfi A, Perelli P, Locatelli M, Ciniglio Appiani G. Microgravity and the intervertebral disc: The impact of space conditions on the biomechanics of the spine. Front Physiol. 2023 Mar 14;14:1124991. doi: 10.3389/fphys.2023.1124991. eCollection 2023.
- Individual participant dataSharing planned: No. Subject's data will be collected in completely anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Marfia, MD, PhD principal investigator
Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force
Emanuele Garzia, MD, PhD study chair
Italian Air Force
Marco Locatelli, MD, PhD study chair
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Injury and Stress Physiological, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Marfia, MD, PhD (0256660100 ext. +39, giovanni.marfia@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of flight-related exposure data and molecular modifications (time frame: Through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.