Cancer Clinical Trial
— PLATONEOfficial title:
Neuromed- Integrated Health Life Platform and Biobank
NCT number | NCT03279991 |
Other study ID # | 51/17 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 4, 2019 |
Est. completion date | May 30, 2023 |
Verified date | November 2023 |
Source | Neuromed IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 4000 |
Est. completion date | May 30, 2023 |
Est. primary completion date | February 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS INM Neuromed, Department of Epidemiology and Prevention | Pozzilli | IS |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
Italy,
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. — View 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. — View 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. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biological sample bank | A repository of biological samples, "Neurobiobank", from patients who will join the project, will be organised at the biotechnology park of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed of Pozzilli under the responsibility of the experienced staff at the Department of Epidemiology and Prevention. | baseline | |
Primary | Integrated health-life big data platform | Analytical tools will be developped for integrating structured and unstructured patients data sets and derive actionable information from their observed interrelationships. | baseline | |
Primary | omics analysis | Measure of genomic, epigenetic and proteomic fingerprint of recruited patients | baseline | |
Primary | Four P (4P) medicine | Identification of patterns within the health data that correlate with disease or wellness and create personalised pathway of prevention and care. | Baseline |
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