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

NCT06372054 | Recruiting DMC

• 1 other identifier: TORNADO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pilots; air force; epigenetic change; environmental exposure

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 3 year

Secondary Outcomes (4)

• Assessment of General Health

  Through study completion, an average of 3 year

• Assessment of Sleep Quality

  Through study completion, an average of 3 year

• Assessment of eating habits

  Through study completion, an average of 3 year

• Creation of reliable AI and disease-based models for personalized medicine

  Through study completion, an average of 3 year

Study Arms (2)

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

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.

Other: Biological sample collection

Interventions

Biological sample collection OTHER

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

High-performance Italian Air Force Pilots; Italian Air Force ground staff

Eligibility Criteria

• Age: 26 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• University of Milan: collaborator
• Italian Air Force: collaborator
• A-Tono: collaborator
• Ministry of Defense, Italy: collaborator

Study Sites (1)

CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy

Milan, 20139, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 35678198 RESULT

• 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.

  PMID: 36998982 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, salivae

Study Officials

• Giovanni Marfia, MD, PhD

  Fondazione IRCCs Ca' Granda Ospedale MAggiore Policlinico, Italian Air Force

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Giovanni Marfia, MD, PhD

CONTACT

0256660100; giovanni.marfia@policlinico.mi.it

Laura Guarnaccia, PhD

CONTACT

0255034268; laura.guarnaccia@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 17, 2024
• Study Start: February 5, 2024
• Primary Completion: February 5, 2025
• Study Completion (Estimated): February 5, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)