Clinical trial NCT03426488: Northern Sweden Health and Disease Study
Official title: Northern Sweden Health and Disease Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Cancer
Neurodegenerative Diseases
Respiratory Disease
Infection
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 120000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Given before

Brief summary: NSHDS (Northern Sweden Health and Disease Study) is an umbrella term for a prospective biobank with related survey data. The sample collection consists of three subcohorts, Västerbotten Intervention Programme (VIP), Mammography Screening Project (MA) and MONICA (MONItoring of Trends and Determinants in CArdiovascular Disease). The blood samples are stored at the Northern Sweden Biobank.

Detailed description: The overall aim of the NSHDS is to support frontline research with particular emphasis on improving diagnostic tools for clinical use, as well as finding early markers of disease, using the blood samples, tissue and associated health data from the NSHDS. Furthermore, basic research regarding risk factors as well as pathogenetic pathways are promoted.

The prospective blood samples and related survey data can be linked to national registries for health outcomes such as cancer diagnosis for which there is a near 100% completeness of the data.

VIP - VÄSTERBOTTEN INTERVENTION PROGRAMME The VIP is a long-term project intended for health promotion of the population of the county of Västerbotten (approximately 254,000 inhabitants). All individuals 40, 50, and 60 years of age in the county are invited for screening. They are asked to complete a questionnaire concerning various lifestyle factors, including diet, and to donate a blood sample to be frozen for later research purposes. The cohort is population-based and the inclusion of individuals started 1985 and is ongoing. The participation rate has ranged between 48 and 67% of the population. But a large number has not been invited for screening. Among those invited the participation rate has been very high. The material is population based.

The blood samples consist primarily of EDTA (ethylenediaminetetraacetic acid) and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat. Questionnaire data are linked to blood samples.

The majority of samples are fasting samples. Number of individuals: 103,100 Individuals with repeated samples: 43,500 Sampling occasions: 151,200 (October 2016)

MA - MAMMOGRAPHY SCREENING PROJECT

Samples and data are collected in connection with mammography screenings 1995-2006. The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat, and for a certain percentage, the DNA is also extracted. The cohort consists of women, 18-82 years old (95% between 48 and 70 years old).

Survey data can be linked to the blood samples.

Individuals: 28,800 Individuals with repeated samples: 14,600 Sampling occasions: 54,000

THE MONICA STUDY

The MONICA study is a longitudinal population-based database for research in cardiovascular disease and diabetes. Since 1985, seven screenings has been performed (1986, 1990, 1994, 1999, 2004, 2009 and 2014) of a randomized selection of the population in the counties of Västerbotten and Norrbotten in Northern Sweden.

Individuals: 11,800 Individuals with repeated samples: 3,500 Sampling occasions: 15,300

This registration will only cover blood sampling (screenings since 1990) and dietary data (optional MONICA study, screenings since 1986) as a part of the National Environmental Biobank. The participation rates have been 69-81%.

A separate registration is expected for the basic MONICA study.

Eligibility criteria: Inclusion Criteria:

* Residents in Northern Sweden

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of deaths
timeFrame: Follow up at least 20 years
measure: Numbers of incident cases of disease.
timeFrame: Follow up at least 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Göran Hallmans, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: