Nijmegen Biomedical Study [NBS]

GENERAL INFORMATION

Name	Nijmegen Biomedical Study
Acronym	NBS
Last update	03/20/2009

Affiliation

• Biobanking and Biomolecular Resources Research Infrastructure [BBMRI]

Principal investigators

Lambertus A. Kiemeney (Prof. dr. Principal Investigator)	Radboud University Nijmegen Medical Centre
Martin den Heijer (Dr. Principal Investigator)	Radboud University Nijmegen Medical Centre
André L.M. Verbeek (Prof. dr. Principal Investigator)	Radboud University Nijmegen Medical Centre
Dorine Swinkels (Prof. dr. Principal Investigator)	Radboud University Nijmegen Medical Centre
Barbara Franke (Dr. Principal Investigator)	Radboud University Nijmegen Medical Centre

Contacts

Femmie de Vegt (Dr. Coordinator)	Radboud University Nijmegen Medical Centre Nijmegen 6500 HB Phone: +31 24 3619132 Email: f.devegt@ebh.umcn.nl
Sita Vermeulen (Dr. Coordinator)	Radboud University Nijmegen Medical Centre Nijmegen 6500 HB Phone: +31 24 3619132 Email: s.vermeulen@ebh.umcn.nl

Website

• http://www.nijmegenbiomedischestudie.nl/

Funding agency

	Percentage	Category
Radboud University Nijmegen Medical Centre	100%	University

BACKGROUND

In the Radboud University Nijmegen Medical Centre, we were performing case-control studies in several diseases. For every study, we had to construct a new control group which was considered not very efficient. We therefore wanted to come to a general control series that we could use every time again for comparisons with different case series. At the same time, we wanted to assess breast cancer risk factor distributions in the general population for comparison with measurements that we obtained in 1975. Our Clinical Chemistry department was interested in serum and plasma measurements in the general population because they had the feeling that many diagnostic reference values were inadequate because these were obtained from convenience samples instead of the general population. We decided to bring these three plans together with a study among the general population of the municipality of Nijmegen.

OBJECTIVES

The aims of the study were:
1. to derive a population based control group as a reference for the distribution of risk factors and genotype frequencies in several diseases that are being studied in the Radboud University Nijmegen Medical Centre, and 2. the evaluate the distribution of genotype frequencies and serum and plasma measurements in the general population in order to obtain reference values for diagnostic purposes in clinical chemistry.

Topics of interest

• Broad approach with no specific topic of interest
• Target specific topics of interest (health outcomes, health determinants, etc.)

Topics	ICD-10 classification
Neoplasms (C00-D48)	all
Endocrine, nutritional and metabolic diseases (E00-E90)	E00-E07, E83.1
Mental and behavioural disorders (F00-F99)	all
Pregnancy, childbirth and the puerperium (O00-O99)	all

METHODS

	Legend Yes No Unknown

General design

Study design	Cross-sectional prevalence
Type of participants	Individuals
Target or final number of participants	10000
Target or final number of DNA	6700

Participant selection / Characteristics of the population

Selection criteria

Age	Minimun: 18 years
Country of residence	Netherlands (Nijmegen)
Other criteria	Capable of reading a Dutch questionnaire.

Recruitment procedures

A random sample of max. N=800 in each gender-specific 5-year age group was drawn from the population register of the Municipality of Nijmegen (which includes the city of Nijmegen and two smaller villages: Lent and Oosterhout). The total sample was 22,500. These selectees were invited to participate in a study on health and gene-environment interactions for disease. The invitation took place by means of a letter accompanied by a brochure and letter of support by the mayor of Nijmegen. A postal questionnaire was also sent together with the invitation letter. The final page of the questionnaire was an informed consent form. The participants could indicate on the informed consent form whether they were willing to donate blood samples.

Data Sources

	Cross-sectional	Repeated/continuous
Questionnaires to participants/respondents
Direct physical measures
Biological samples
Medical paper
Electronic databases
Genealogical records

Collection procedures

A postal questionnaire was sent together with an invitation letter. Participants could return their completed questionnaire + informed consent form in a prepaid envelope. An appointment was made for a blood donation and blood samples were taken by the regional Thrombosis services. If needed, participants were visited at home for these blood collections. In a second phase of the study, participants were invited to come to the University for anthropometric measurements, non-invasive blood vessel measurements, blood and urine collection.

Follow up procedures

1. In a more or less ad hoc way, participants are approached with invitations to fill out additional questionnaires or show up for additional physical measurements;
2. Weekly reports are obtained from the Population Register with changes of address or vital status;
3. Linkage takes place with the population-based cancer registry.

Baseline principal variables of interest

Health information

• Diseases history - ICD-10 All conditions
• Medication intake
• Familial disease history
• Early life
• Women's health
• Quality of life

Physical / Biochemical measures

Body structure measures	Biochemical measures
Body function measures

Sociodemographic Characteristics

Birth location	Parents birth location
Ethnicity/Race	Gender
Marital status	Date of birth

Socioeconomic Characteristics

Education level	Income
Working status

Life habits / Behaviours

Physical activity	Smoking / Tobacco Use
Nutrition	Alcohol intake

Physical environment

Passive smoking

Mobile phone use

Sample management

Biological samples

Blood	Buccal cells
Cord blood	Tissues
Saliva	Urine

Biological samples format

	Fresh	Frozen	Dried (paper)	Other	Specification
Blood

Genome-Wide Association (GWA) analyses

• Already or currently generating GWA data. Approximate number of participants : 2000

GOVERNANCE

	Legend Yes No

Allow access to data or samples to external researchers

	Academia	Industry
Data (questionnaire-derived, measured…)
Biological samples

STATUS

Current status

Phase	Start	End
Preparation phase/Pilot	2001	2002
Recruitment / initial data collection	2002	2004
Follow-up of participants	2002	2025
Study ended		2025

Current number of participants recruited	10000 in date of 07/01/2002

Current number of collected DNA samples	6700 in date of 07/01/2002

AVAILABLE DOCUMENTS

	Document type	Availability
1	General study protocol	s.vermeulen@ebh.umcn.nl
2	Specific protocols/procedures (data collection, samples management, etc.)	s.vermeulen@ebh.umcn.nl
3	Questionnaires	s.vermeulen@ebh.umcn.nl
4	Consent forms	s.vermeulen@ebh.umcn.nl
5	Pamphlet / project description	s.vermeulen@ebh.umcn.nl

DOCUMENTATION

• NBS Publication List

General information

Name	Physical and cognitive measures
Last update	08/26/2009
Collected at phase	2
Year interval	2005 to 2008
Supplementary informations	Physical and cognitive measures are collected in the second phase of the NBS (and not at baseline) in part of the NBS participants; different tests were applied to participants betweeen 50 and 70 years of age (focus on anthropometric and cardiovascular function) and those older than 70 years (focus on cognitive measurements and executive functions).

Contacts

Sita H. Vermeulen (Dr. Coordinator)

Department of Epidemiology, Biostatistics, and HTA; Radboud University Nijmegen Medical Centre Nijmegen 6500 HB Phone: 031243613127 Email: s.vermeulen@ebh.umcn.nl

Physical and cognitive measures collected

	Legend Yes No

BODY STRUCTURES

ANTHROPOMETRIC STRUCTURES

Anthropometric measures

Weight

Height

Standing height

Body circumferences

Waist circumference

Hip circumference

BODY FUNCTIONS

MENTAL FUNCTIONS

Global mental functions

Cognitive functions (Mini-Mental State Examination (MMSE))

Other global mental functions (e.g. IQ) (Stroop Color Word Test was used as test of response inhibition)

Specific mental functions

Memory functions (Subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB), which includes the Paired Associates Learning (PAL) to assess learning and episodic memory, and Pattern Recognition Memory (PRM) to assess visual recognition memory)

Psychomotor functions (Trail Making Test (TMT))

FUNCTIONS OF THE CARDIOVASCULAR AND RESPIRATORY SYSTEMS

Functions of the cardiovascular system

Blood pressure (a.o. ankle-brachial index: blood pressure in arms and feet prior and after exercise)

Other measures of the cardiovascular functions (Pulse wave velocity; plack thickness IMT; FMD NMD)

NEUROMUSCULOSKELETAL AND MOVEMENT-RELATED FUNCTIONS

Other measures of the neuromusculoskeletal system and movement-related function (Quantitative gait analysis was performed with a 5.6-meterlong, 0.89-meter-wide electronic walkway (GAITRite; CIR Systems Inc, Havertown, PA) with sensor pads (12.7 mm apart from each other) connected to a computer.)

Administration mode

	Legend Yes No

Administration environment

Hospital, clinic, university or recruitment center

Participant residence

Other

Staff administering test

Professionals (nurses, clinicians, etc)

Interviewers/research assistants

Other

Documentation on procedures

Administration language	Dutch

Reporter comments

SOPs can be obtained from the coordinator; description of procedures can also be found in following papers: S. Holewijn et al., Eur J Clin Invest. 2009 Jul;39(7):554-60; M.B. van Iersel et al., J Gerontol A Biol Sci Med Sci. 2008 Dec;63(12):1344-9.

General Information

Name	DNA Processing
Study name	Nijmegen Biomedical Study [NBS]
Last update	09/14/2009

Contact

Sita H. Vermeulen (Dr. Coordinator)

Department of Epidemiology, Biostatistics, and HTA; Radboud University Nijmegen Medical Centre Nijmegen 6500 HB Phone: 031243613127 Email: s.vermeulen@ebh.umcn.nl

Utilization conditions	NBS has protocols for DNA extraction and normalization. Protocols are not attached as none of them may be copied or distributed. Details can be given upon request.

Samples

	Legend Yes No

Sample name		Blood
	Main laboratory	Radboud University Nijmegen Medical Centre Clinical Chemistry
	Sample labels/traceability (% of samples)	RFID radio frequency identification Barcode (1D and 2D) Printed labels Handwritten numbers Others
Pre-extraction sample storage format	Substrate storage condition	Fresh Refrigerated Frozen (-80°C) Dried (paper) Liquid Nitrogen Other
	Substrate storage period	Short term Long term (2 years)
DNA extraction	DNA extraction method	Salting out Phenol-chloroform Columnary-extraction Magnetic beads Oragene (saliva) Others
	Automation of handling	Manual Automated
DNA handling and storage	DNA diluent	TE H2O Others
	DNA concentration (ng/µl)	100
	Storage conditions	4°C -20°C -40°C -80°C Dried Others
DNA quantification	Methods	A260/A280 Picogreen Nanodrop Others
	Technical quality	Automated Manual Reproducibility
DNA quality control	Percentage of samples that are tested
	DNA quality method	Agarose gel PCR A260/A280 ratio Others
DNA analysis	Platforms	Gentoyping Sequencing Methylation CNVs CGH FISH Other
	Technical quality	Automated Manual Reproducibility

General Information

Name	Information Technologies
Study name	Nijmegen Biomedical Study [NBS]
Last update	08/25/2009

Contact

Sita H. Vermeulen (Dr. Coordinator)

Department of Epidemiology, Biostatistics, and HTA; Radboud University Nijmegen Medical Centre Nijmegen 6500 HB Phone: 031243613127 Email: s.vermeulen@ebh.umcn.nl

Software

	Legend Yes No

Software overview

Biobanking areas covered	TeleForm 10	Access	SAS 8.2	SPSS 16.0	Stata 9
Participant recruitment (ex: CATI, CRM)
Data collection
Sample collection, storage and processing
Data repository
Other
Programming language	TeleForm 10	Access	SAS 8.2	SPSS 16.0	Stata 9
Name and version of programming language
Internal/external development	TeleForm 10	Access	SAS 8.2	SPSS 16.0	Stata 9
In-house by IT department
By an external company
Shareability	TeleForm 10	Access	SAS 8.2	SPSS 16.0	Stata 9
Freely available
Purchaseable
Needs extensive work
Not for share

Software details

Comments

No information available