Leader: Daniela Capello (UPO); Other collaborator(s): Lorenzo Schiavon (UNIVE)
Design and pilot a novel and innovative cohort study on aging enrolling and carry out a longitudinal and cross-sectional collection and analysis of biological, health, life-style and socioeconomic data to fill gaps of previous and already available cohorts
The Novara Cohort Study, launched on November 7, 2023, has made significant strides since its inception.
Scientific Paper Under Submission: A scientific paper detailing the outcomes of the pilot study involving 123 participants is currently undergoing submission. This paper promises to offer valuable insights into the initial findings and methodologies employed in the study. Enrollment Success: By March 15, 2024, the study has exceeded expectations, with over 200 participants already enrolled and more than 300 awaiting inclusion. This high level of enrollment demonstrates strong community engagement and interest in the study. Passive Follow-Up Protocols: Efforts are underway to establish protocols for passive follow-up, enabling the collection of longitudinal data from hospitals and local health centers. This aspect of the study will provide valuable insights into health trends over time. Laboratory Analyses: Ongoing proteomic and metabolomic analyses are being conducted on biological samples collected from participants. These analyses will contribute to a deeper understanding of biological markers associated with aging and health outcomes. Focus Groups and Questionnaires: In the near future, focus groups will be convened, and questionnaires will be administered to participants to evaluate their motivations, satisfaction, and perceived effects of participation. This qualitative data will complement quantitative findings and provide valuable insights into participant experiences. National Congress on Health Data and Biobanking: The convening of a national congress on "Health Data, Biobanking, and Biomedical Research: Opportunities and Challenges" on October 5, 2023, provided a crucial platform for discussing key issues in healthcare data management and biobanking practices. The event likely facilitated collaboration and knowledge exchange among stakeholders in the biomedical research community.
Brief description of the activities and of the intermediate results
The Novara Cohort Study (NCS) is a longitudinal research project aimed at evaluating the long-term health and aging outcomes of citizens in the Novara area. It involves a comprehensive collection of biological samples and detailed demographic, lifestyle, clinical, and biological data. Data management is done in collaboration with the UPO Biobank, ensuring proper storage and future access for analysis. The recruitment process remains a key component of the study, with 300 participants currently enrolled.
A study has been initiated to evaluate the perception and lifestyle impact of participating in the project.
Main policy, industrial and scientific implications
Contact has been made with patient associations and several biotech companies for the establishment of a stakeholder committee and the drafting of a collaboration agreement with the NCS and UPO Biobank activities.
The project has been presented to general practitioners, highlighting that health data generated by the study may help in implementing preventive healthcare actions for their patients. The number of samples and data collected is sufficiently representative and adequate to begin association analyses between health outcomes and hematochemical parameters evaluated at the time of participation.
Brief description of the activities and of the intermediate results
Recruitment continues successfully, with 500 participants now involved and at least 700 awaiting participations. A paper has been submitted that describes the pilot study and provides a characterization of the population involved so far, based on demographic, health, and hematochemical data.
A project has also been launched, involving focus groups aimed at evaluating personal perceptions of aging.
Main policy, industrial and scientific implications
An update is underway for the study's information sheet, consent form, and a protocol for sharing health data with ASL Novara. This collaboration lays the groundwork for building a fruitful interaction between research and local healthcare services, marking the first and only experience of its kind in the Piedmont region.
The data collected thus far allows the launch of an integrated study using deep learning techniques to analyze hematochemical parameters and functional data to define a laboratory index for frailty, the most frequent and socio-economically impactful form of accelerated aging.
Brief description of the activities and of the intermediate results
Recruitment is progressing successfully, with 700 participants already enrolled and at least 700 more awaiting participation. Efforts continue to engage a diverse population, ensuring representation across different age groups and backgrounds.
Main policy, industrial and scientific implications
As part of the study’s social and psychological assessment, approximately 300 participants have completed questionnaires exploring their experience of participating in the Novara Cohort Study (NCS). These surveys aim to assess perceptions, motivations, and the perceived benefits or concerns related to long-term involvement in the study.
Data analysis is currently underway and will be complemented by qualitative interviews to gain deeper insights into participants' perspectives. The findings will be synthesized into a publication analyzing the perception and impact of NCS participation among Novara citizens, contributing to the broader discussion on public engagement in longitudinal cohort studies
Laboratory data, questionnaires, and physical tests related to motor capacity and autonomy are being collected to identify biochemical profiles associated with frailty.
Information on cognitive reserve and the Montreal Cognitive Assessment (MoCA)—a screening tool for mild cognitive impairment—is being gathered and analyzed in relation to the Big Five Inventory (BFI), which assesses personality traits.
The Novara Cohort Study (NCS) has enrolled 800 participants, collecting biological samples, clinical information, and lifestyle data in collaboration with UPO Biobank. Olink proteomic analysis of inflammatory biomarkers has been conducted on a subset of 150 participants. Additionally, hematochemical analyses assessing inflammation and organ function—including liver, kidney, and cardiovascular parameters—have been completed for over 500 participants.
The Novara Cohort Study (NCS) has enrolled 950 participants, collecting biological, clinical, and lifestyle data in collaboration with UPO Biobank. A study on participants’ perceptions and the impact of study participation on lifestyle—based on questionnaires and interviews—has been completed, and a manuscript is in preparation. The cohort profile, describing the optimization and implementation of new measurements and questionnaires derived from the pilot phase, has been submitted for publication. A protocol for sharing health data with ASL Novara is currently being finalized to foster integration between research and healthcare.
Analyses are ongoing to develop a frailty index based on hematochemical and functional parameters.
Hematochemical and inflammatory plasma protein markers from 850 individuals are also under analysis for a forthcoming manuscript. A public event will be held on September 19 to present preliminary results to local institutions and the wider community.
Genotyping of 500 participants is currently underway.
Brief description of the activities and of the intermediate results
During the July–September period, recruitment activities continued successfully, reaching approximately 1,200 participants. Large-scale molecular analyses were advanced through the initiation of whole-genome sequencing for 1,000 participants, enabled by competitive access to the National Sequencing Facility at Human Technopole and funded by the Italian Ministry of University and Research (MUR). In parallel, genotyping and targeted proteomic analyses were completed in 500 participants, supporting integrated investigations of genotype–phenotype relationships, with a specific focus on inflammation-related pathways and physical frailty. During this period, the study team also actively participated in ELSI working groups within BBMRI.it, contributing to the development of ethical, legal, and governance frameworks for biobanking in population-based studies.
Main policy, industrial and scientific implications
Public engagement and citizen science activities represented a key component of this period. On 19 September, the Novara Cohort Study Day was organized as a dedicated event for the local community, aimed at presenting study objectives, activities, and emerging results, and at fostering dialogue between researchers and citizens. The event, complemented by a photographic contest, promoted principles of participatory research, transparency, and scientific citizenship, reinforcing participants' trust and long-term engagement. From a scientific perspective, the availability of genomic, genotyping, and proteomic data strengthens the NCS as a platform for precision aging research and supports its integration within national and European research infrastructures.
Brief description of the activities and of the intermediate results
During the October–December period, recruitment activities continued, with the Novara Cohort Study exceeding 1,400 enrolled participants. A standardized assessment using Tanita bioelectrical impedance analysis (BIA) was introduced to strengthen the multidimensional evaluation of physical frailty, body composition, and muscle mass, providing objective indicators relevant to aging, sarcopenia, and functional decline. In parallel, new and optimized questionnaires were implemented to improve the assessment of risk factors for mild cognitive impairment (MCI). Preparatory activities were also initiated to define a dedicated protocol for the involvement of individuals at first diagnosis of neurodegenerative disorders in NCS, in collaboration with the Neurology Unit of AOU Maggiore, Novara, to reinforce the integration between population-based research and clinical pathways.
During this period, two scientific manuscripts were submitted or accepted, further consolidating the Novara Cohort Study as a reference population-based platform for aging research. A mixed-methods study has been submitted to The Gerontologist (Tucci R., Garro G., et al.) This study investigates how participation in the NCS influences health awareness, health literacy, and self-reported behaviours, providing evidence on the societal impact of population-based aging research. In addition, a cohort profile update describing the evolution of the NCS protocol, including expanded phenotyping, governance, and data infrastructure, has been accepted for publication in BMJ Open (Cracas et al., in press), highlighting the study’s scalability and long-term sustainability.
Main policy, industrial and scientific implications
During this period, dissemination focused on scientific valorization through manuscript preparation and submission. Two scientific manuscripts were submitted or accepted, further consolidating the NCS as a reference population-based platform for aging research.