Neuromed- Integrated Health Life Platform and Biobank

NCT03279991 | Completed

• 1 other identifier: 51/17
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Neuro-Degenerative Disease; Cancer; Pregnancy

Keywords

biobank; chronic disease; omics; big data; 4 P medicine

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• omics analysis

  Measure of genomic, epigenetic and proteomic fingerprint of recruited patients

  baseline

• 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted in the Neuromed group clinics who will have signed informed consent

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS INM Neuromed, Department of Epidemiology and Prevention

Pozzilli, IS, 86077, Italy

Location

Related Publications (5)

• 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.

  PMID: 27665228 BACKGROUND

• 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.

  PMID: 24762252 BACKGROUND

• 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.

  PMID: 21749975 BACKGROUND

• 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.

  PMID: 28518059 BACKGROUND

• 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.

  PMID: 27521224 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The residual portion of biological withdrawals and materials normally used for the patient's therapeutic diagnostic route ( blood, urine, any fragments of biopsy tissue, surgical finds, umbilical cord, placenta sections, cephalorachidian fluid etc). In order to carry out any genetic-molecular investigations, DNA and DNA from these biological fluids and tissues will be extracted.

MeSH Terms

Conditions

Cardiovascular Diseases; Neoplasms; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• licia Iacoviello, MD, PhD

  IRCCS Neuromed

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 12, 2017
• Study Start: March 4, 2019
• Primary Completion: February 27, 2023
• Study Completion: May 30, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Upon request
• Access Criteria: Approval by the Moli-sani study Scientific committee

Locations

IT (1)