Clinical trial NCT03279991: Neuromed- Integrated Health Life Platform and Biobank
Official title: Neuromed- Integrated Health Life Platform and Biobank
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Neuro-Degenerative Disease
Cancer
Pregnancy
Keywords: biobank
chronic disease
omics
big data
4 P medicine
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in the Neuromed group clinics who will have signed informed consent

Brief summary: This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

Detailed description: There is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of Copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. From these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease.

An Integrated Health Life Platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with A virtual community.

The platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and The relationships that come to them and from them. The platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.

Eligibility criteria: Inclusion Criteria:

* Men and women
* Older than 18 years
* Cardiovascular disease
* neurodegenerative disease
* Cancer
* Pregnancy

Exclusion Criteria:

* Inability to understand and to want
* Refusal to sign the informed consent

Primary outcomes:
measure: Biological sample bank
timeFrame: baseline
measure: Integrated health-life big data platform
timeFrame: baseline
measure: omics analysis
timeFrame: baseline
measure: Four P (4P) medicine
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS INM Neuromed, Department of Epidemiology and Prevention
state: IS
Study officials:
affiliation: IRCCS Neuromed
name: licia Iacoviello, MD, PhD
role: STUDY_CHAIR
References:
citation: GBD 2015 SDG Collaborators. Measuring the health-related Sustainable Development Goals in 188 countries: a baseline analysis from the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1813-1850. doi: 10.1016/S0140-6736(16)31467-2. Epub 2016 Sep 21.
citation: Iacoviello L, De Curtis A, Donati MB, de Gaetano G. Biobanks for cardiovascular epidemiology and prevention. Future Cardiol. 2014 Mar;10(2):243-54. doi: 10.2217/fca.13.110.
citation: Fortier I, Doiron D, Burton P, Raina P. Invited commentary: consolidating data harmonization--how to obtain quality and applicability? Am J Epidemiol. 2011 Aug 1;174(3):261-4; author reply 265-6. doi: 10.1093/aje/kwr194. Epub 2011 Jul 11.
citation: Kim DH, Kim YS, Son NI, Kang CK, Kim AR. Recent omics technologies and their emerging applications for personalised medicine. IET Syst Biol. 2017 Jun;11(3):87-98. doi: 10.1049/iet-syb.2016.0016.
citation: Duffy MJ, O'Donovan N, McDermott E, Crown J. Validated biomarkers: The key to precision treatment in patients with breast cancer. Breast. 2016 Oct;29:192-201. doi: 10.1016/j.breast.2016.07.009. Epub 2016 Aug 9.