TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models

• ClinicalTrials.gov Identifier: NCT06372054
• Recruitment Status: Recruiting
• First Posted: April 17, 2024
• Last Update Posted: April 17, 2024
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: University of Milan; Italian Air Force; A-Tono; Ministry of Defense, Italy
• Information provided by (Responsible Party): Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Tracking Information

• First Submitted Date: March 21, 2024
• First Posted Date: April 17, 2024
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: February 5, 2024
• Estimated Primary Completion Date: February 5, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2024)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 16, 2024)

• Assessment of General Health [ Time Frame: Through study completion, an average of 3 year ]
  Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI)
• Assessment of Sleep Quality [ Time Frame: Through study completion, an average of 3 year ]
  Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ)
• Assessment of eating habits [ Time Frame: Through study completion, an average of 3 year ]
  Recording of eating habits by Food Frequency Questionnaire (EPIC)
• Creation of reliable AI and disease-based models for personalized medicine [ Time Frame: Through study completion, an average of 3 year ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models
• 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
• Brief 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 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years

Biospecimen

Retention:   Samples With DNA

Description:

Blood, urine, salivae

• Sampling Method: Non-Probability Sample
• Study Population: The study population will consist of high-performance Italian Air Force pilots, compared to Italian Air Force ground staff.

Condition

• Oxidative Injury
• Stress Physiological
• Discogenic Pain
• Cardiovascular Risk Factor
• Space Maintenance
• Epigenetic Changes
• LONGEVITY 1
• Neuroplasticity
• NGS

Intervention

Other: Biological sample collection

Collection of biological samples (blood, urine, saliva) and clinical data

Study Groups/Cohorts

• 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

  Intervention: 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.
  Intervention: Other: Biological sample collection

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.
• Marfia 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 16, 2024): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 5, 2027
• Estimated Primary Completion Date: February 5, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age < 25 years and > 39 years
• no signature on informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 26 Years to 38 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Giovanni Marfia, MD, PhD; 0256660100 ext +39; giovanni.marfia@policlinico.mi.it

Contact: Laura Guarnaccia, PhD; 0255034268 ext +39; laura.guarnaccia@policlinico.mi.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT06372054
• Other Study ID Numbers: TORNADO
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Subject's data will be collected in completely anonymized form.

• Current Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Original Responsible Party: Same as current
• Current Study Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Original Study Sponsor: Same as current

Collaborators

• University of Milan
• Italian Air Force
• A-Tono
• Ministry of Defense, Italy

Investigators

• Principal Investigator: Giovanni Marfia, MD, PhD; Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force
• Study Chair: Emanuele Garzia, MD, PhD; Italian Air Force
• Study Chair: Marco Locatelli, MD, PhD; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Study Chair: Francesco Vestito, PhD; Italian Air Force

• PRS Account: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Verification Date: March 2024