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Chronic DiseaseCOHORTENCT05852678

A Population-based Cohort in Northern Spain

An observational study of Chronic Disease, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cantabria Cohort stems from a research and action initiative lead by researchers from Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital and University of Cantabria, supported by the regional Goverment. Read more about this study

Who is it for?
Ages 40 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Disease
What is being tested?
cohort
How many people
22,000 participants
Where
1 siteSpain
Study dates
20 Apr 2021to 1 Apr 2045
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Residents in the autonomous community of Cantabria

Who may be able to join

  • Participants between 40-69 years of age
  • Participants who sign the informed consent form
  • Participants legally residing in Cantabria

Who cannot join

  • Participants under 40 years of age and over 69 years of age
  • Participants not signing the informed consent form
  • Participants not legally residing in Cantabria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site, 1 recruiting
  • Hospital Universitario Marques de Valdecilla

    Santander, 39011

    Marcos Lopez-Hoyos, 942315515, marcos.lopez@scsalud.es

    Recruiting

Other trials in Spain

About this study

Official title: The Cantabria Cohort, a Protocol for a Population-based Cohort in Northern Spain

Cantabria Cohort stems from a research and action initiative lead by researchers from Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital and University of Cantabria, supported by the regional Goverment. Its aim is to identify and follow up a cohort that would provide information to improve the understanding of the etiology and prognosis of different acute and chronic diseases. The Cantabria Cohort will recruit between 40,000-50,000 residents aged 40-69 years at baseline, representing 10-20% of the target population. Currently, more than 22,000 volunteers have been enrolled. All participants will be invited for a re-assessment every three years, while the overall duration is planned for twenty years. The repeated collection of biomaterials combined with broad information from participant questionnaires, medical examinations, actual health system records and other secondary public data sources is a major strength of its design, which will make it possible to address biological pathways of disease development, identify new factors involved in health and disease, design new strategies for disease prevention, and advance precision medicine. It is conceived to allow access to a large number of researchers worldwide to boost collaboration and medical research.

Read the detailed description

Recent reports have shown that non-communicable diseases, especially cardiovascular and metabolic diseases, were the main cause of morbi-mortality in Spain in 2019. Therefore, risks factors related to lifestyle, behavior and environment are placing a heavy burden on the Spanish population's health. At the same time, incidence of these diseases and an aging population threaten the sustainability of the Spanish universal health system. That stated, preventive, predictive and personalized medicine are urgently needed; to achieve such an aim, extensive data and knowledge will be fundamental.

Long-term follow-up cohort studies have played a crucial role in understanding modifiable factors associated with the development of chronic disease. In the early 1950s, initial results from the Framingham Health Study were published, beginning a new era in epidemiology . Large prospective cohort studies have established themselves as the most appropriate epidemiological design for research in the field of multimorbidity in real-life conditions. Over the last decades, the number of large prospective cohorts have increased.

The Framingham Health study selected its study population from a well-defined geographic area, the city of Framingham (Massachusetts, USA). This same strategy was carried out in Europe. One of the most remarkable examples was that of the European Prospective Investigation into Cancer and Nutrition (EPIC), which was an initiative of the International Agency for Research on Cancer (IARC). More recently, national cohort studies have been developed.

In Spain, several efforts have been undertaken to establish prospective, population-based cohorts. However, to date, long-term, population-based and multipurpose studies covering a specific territory have not been attemped. Conversely, a national cohort study has just been launched. Health system management in Spain takes place at the regional (autonomous community) level, which in practice results in 17 autonomous health systems within Spain.

In this context, the Cantabria Cohort was launched in late 2020 and it includes residents in Cantabria, an autonomous community located in northern Spain. Cantabria covers an area of 5,330 km², hosting a total population of 584,507 inhabitants, 45% living in the region's capital. Moreover, the Cantabrian Public Health System is organized into 42 health areas for primary care. It has four hospitals; the Hospital Universitario Marqués de Valdecilla (HUMV) is the tertiary and referenced hospital in the region. This center helps implement large-scale studies, reducing the necessity of coordination among different institutions and procedures. Further, due to the widespread COVID-19 vaccination campaign in 2021, a huge effort to integrate multiple public databases and update contact information of the population has facilitated the start of the project. Cantabria Cohort stems from a research and action initiative to improve the regional health system and advance the health-related Sustainable Development Goals. The present paper describes the design and implementation of the Cantabria Cohort and the processes related to the biological sample collection and data acquisition. It also provides an overview of the governing board, quality assurance, and legal and ethical aspects, as well as future research opportunities and cooperation.

Conditions
Chronic Disease
Being tested
cohort
Keywords
Lifestyle, Socio-economic factors, Biobank, Big data, Precision medicine, Longitudinal study
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cohortOther

    The Cantabria Cohort will recruit 40,000-50,000 residents aged 40-69 years at baseline

Study groups in NCT05852678
Study groupRoleWhat they receive
Patient registryThe Cantabria Cohort will recruit 40,000-50,000 residents aged 40-69 years at baseline
Receives: Other: cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Integration and use of real-world data to improve health research

    Measured: 20 years

  2. Identifying lifestyle risk factors and their involvement in chronic diseases

    Measured: 20 years

  3. Evaluation of geographic and socio-economic disparities in health and healthcare

    Measured: 20 years

  4. Assessing biomarkers for the early detection of diseases and disease risks

    Measured: 20 years

  5. Surveillance of viral hepatitis and HIV in Cantabria

    Measured: 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start20 Apr 2021
  3. Primary completion1 Apr 2045 (estimated)
  4. Study completion1 Apr 2045 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852678
Sponsor's protocol ID
COHORTE CANTABRIA
Other IDs
2021.057
Acronym
COHORTE
Status last verified
Apr 2023
First submitted
2 May 2023
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Disease, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Integration and use of real-world data to improve health research (time frame: 20 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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