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Northern Sweden Health and Disease Study (NSHDS)

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ClinicalTrials.gov Identifier: NCT03426488
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Umeå University

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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Cancer Neurodegenerative Diseases Respiratory Disease Infection Behavioral: VIP - Västerbotten Intervention Programme

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.


Study Type : Observational
Estimated Enrollment : 120000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Northern Sweden Health and Disease Study
Actual Study Start Date : January 1986
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Group/Cohort Intervention/treatment
Västerbotten Intervention Programme

The cohort is population-based and consists of blood and data from primarily 40, 50 and 60 year olds, taken every year in this age group in connection with the Västerbotten health surveys from 1985 - present.

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 extracted.

The database NSDD (Northern Sweden Diet Database) consists of survey data from VIP concerning nutritional factors.

A large part is fasting samples.

Individuals: 105,700 Individuals with repeated samples: 40,700 Sampling occasions: 156,300

Behavioral: VIP - Västerbotten Intervention Programme
Intervention on CVD (cardiovascular disease) and diabetes

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 Northern Swedish MONICA Project

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 (March 2015)




Primary Outcome Measures :
  1. Number of deaths [ Time Frame: Follow up at least 20 years ]
  2. Numbers of incident cases of disease. [ Time Frame: Follow up at least 20 years ]

Biospecimen Retention:   Samples With DNA
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 extracted.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Given before
Criteria

Inclusion Criteria:

  • Residents in Northern Sweden

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426488


Contacts
Contact: Göran Hallmans, MD, PhD +46706382516 goran.hallmans@umu.se
Contact: Åsa Ågren, Databasehead +46907852862 asa.agren@umu.se

Locations
Sweden
Umeå University Recruiting
Umeå, Västerbotten, Sweden, 90187
Contact: Lena Jakobsson, Coordinator    +46907858643    lena.jakobsson@umu.se   
Contact: Åsa Ågren, Databasehead    +46907852862    asa.agren@umu.se   
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Göran Hallmans, MD PhD Umeå University

Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03426488     History of Changes
Other Study ID Numbers: Umu
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Neurodegenerative Diseases
Nervous System Diseases