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.
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
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39011
Marcos Lopez-Hoyos, 942315515, marcos.lopez@scsalud.es
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 group | Role | What they receive |
|---|---|---|
| Patient registry | The 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.
Integration and use of real-world data to improve health research
Measured: 20 years
Identifying lifestyle risk factors and their involvement in chronic diseases
Measured: 20 years
Evaluation of geographic and socio-economic disparities in health and healthcare
Measured: 20 years
Assessing biomarkers for the early detection of diseases and disease risks
Measured: 20 years
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.
- First posted10 May 2023
- Study start20 Apr 2021
- Primary completion1 Apr 2045 (estimated)
- Study completion1 Apr 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cantabria Cohort, a Protocol for a Population-based Cohort in Northern Spain
- ClinicalTrials.gov ID
- NCT05852678
- Acronym / sponsor ID
- COHORTE / COHORTE CANTABRIA
- Conditions
- Chronic Disease
- Keywords
- Lifestyle, Socio-economic factors, Biobank, Big data, Precision medicine, Longitudinal study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Apr 2045 (estimated)
- Study completion
- 1 Apr 2045 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient registry | – | Other: cohortThe Cantabria Cohort will recruit 40,000-50,000 residents aged 40-69 years at baseline |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in the autonomous community of Cantabria
Key inclusion criteria (3 listed)
- Participants between 40-69 years of age
- Participants who sign the informed consent form
- Participants legally residing in Cantabria
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cohortThe Cantabria Cohort will recruit 40,000-50,000 residents aged 40-69 years at baseline | Other | Patient registry |
Primary outcome
Integration and use of real-world data to improve health research
Time frame: 20 years
Identifying lifestyle risk factors and their involvement in chronic diseases
Time frame: 20 years
Evaluation of geographic and socio-economic disparities in health and healthcare
Time frame: 20 years
Assessing biomarkers for the early detection of diseases and disease risks
Time frame: 20 years
Surveillance of viral hepatitis and HIV in Cantabria
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.