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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06372054
Other study ID # TORNADO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 5, 2024
Est. completion date February 5, 2027

Study information

Verified date March 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Giovanni Marfia, MD, PhD
Phone 0256660100
Email giovanni.marfia@policlinico.mi.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 5, 2027
Est. primary completion date February 5, 2025
Accepts healthy volunteers No
Gender All
Age group 26 Years to 38 Years
Eligibility 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

Study Design


Intervention

Other:
Biological sample collection
Collection of biological samples (blood, urine, saliva) and clinical data

Locations

Country Name City State
Italy CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy Milan

Sponsors (5)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico A-Tono, Italian Air Force, Ministry of Defense, Italy, University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View Citation

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? Challeng — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Assessment of General Health Recording of general health condition and work stress by General Health Questionnaire by the Effort-Reward Imbalance Questionnaire (ERI) Through study completion, an average of 3 year
Secondary Assessment of Sleep Quality Recording of sleep quality by the Sleeping Quality Questionnaire (SQQ) Through study completion, an average of 3 year
Secondary Assessment of eating habits Recording of eating habits by Food Frequency Questionnaire (EPIC) Through study completion, an average of 3 year
Secondary 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 Through study completion, an average of 3 year
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