Plain English Summary
Background and study aims
Laboratory tests are essential to diagnose issues and make treatment decisions. Interpretation of individual results relies on accurate reference intervals and decision limits. A lot of resources are spent on elderly patients but we know very little about accurate reference intervals. The SENIORLAB study aims to address this gap of knowledge by investigating a large variety of laboratory parameters in clinical chemistry, haematology and immunology.
Who can participate?
Senior individuals aged 60 or above, residing in Switzerland and describing themselves as healthy.
What does the study involve?
This is an observational study which involves a visit to the study centre. There will be basic measurements (blood pressure, weight and height) and a fasting blood test. Then participants will be periodically contacted every 3 to 5 years to evaluate their health status.
What are the possible benefits and risks of participating?
Participants receive a selection of results from laboratory tests relevant for healthy seniors (such as glucose, HbA1c, and creatinine). The risk of participation can be considered to be very low and relates to the risk of phlebotomy of a peripheral vein, usually in the cubital region.
Where is the study run from?
Labormedizinisches Zentrum Dr. Risch in Liebefeld (Switzerland)
When is the study starting and how long is it expected to run for?
January 2007 to December 2025
Who is funding the study?
INOVA Foundation (Liechtenstein)
Who is the main contact?
1. Dr Martin Risch (martin.risch@ksgr.ch)
2. Dr Lorenz Risch (lorenz.risch@risch.ch)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Martin Risch
ORCID ID
Contact details
Kantonsspital Graubünden
Zentrallabor
Loësstrasse 170
Chur
7000
Switzerland
Type
Public
Additional contact
Dr Lorenz Risch
ORCID ID
http://orcid.org/0000-0003-2692-6699
Contact details
Labormedizinisches Zentrum Dr. Risch
Waldeggstrasse 37
Liebefeld
3097
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
SENIORLAB: a prospective observational study investigating laboratory parameters and their reference intervals in the elderly
Acronym
SENIORLAB
Study hypothesis
In clinical practice, laboratory results are very often important when it comes to make diagnostic, therapeutic and prognostic decisions. Interpretation of individual results relies on accurate reference intervals and decision limits. Despite a considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are only rarely available. The SENIORLAB study was set out to address this gap of knowledge determining reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology.
Ethics approval
Ethics Committee Bern (Kantonale Ethikkommission Bern; KEK), 05/01/2009 & 29/07/2013 (amendment), ref: 166/08
Study design
Single-center observational trial
Primary study design
Observational
Secondary study design
Epidemiological study
Trial setting
Community
Trial type
Quality of life
Patient information sheet
http://seniorlabor.ch/index.php?TPL=10062
Condition
Subjectively healthy elderly persons aged 60 and over
Intervention
An extensive baseline evaluation is undertaken in the study participants. The participants are followed up for quality of life, morbidity and mortality.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Evaluation of robust reference intervals
Secondary outcome measures
1. Associations between different parameters
2. Diagnostic characteristics of parameters to diagnose different circumstances
3. Prevalence of occult disease in subjectively healthy individuals
4. Risk factors for outcomes
Overall trial start date
01/01/2007
Overall trial end date
31/12/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 60 or older
2. Resident in Switzerland
3. Subjective perception of being healthy
4. Fasting state when going for baseline examination
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
1500
Participant exclusion criteria
1. Known diabetes mellitus
2. Known thyroid disease
3. Current glucocorticoid use
4. Active neoplastic disease during the past 5 years
5. Consumption of more than 5 pharmacologically active substances (polypharmacy)
6. Hospitalisation during the past 4 weeks
Recruitment start date
28/05/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Switzerland
Trial participating centre
Labormedizinisches Zentrum Dr. Risch
Waldeggstrasse 37
Liebefeld
3097
Switzerland
Funders
Funder type
Research organisation
Funder name
INOVA Research Foundation (Forschungs- und Förderstiftung INOVA) Principality of Liechtenstein
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Study results are disseminated as original reports in peer-reviewed scientific journals, systematic reviews, as well as contributions to scientific meetings, as follows:
1. Publications of cross-sectional analyses are ongoing since 2012
2. The method paper of the prospective study will be submitted in June 2015
3. Publication of reference intervals will be continuously submitted starting from the second half 2015
4. Longitudinal analyses will be continuously published beginning 2017
Intention to publish date
31/12/2015
Participant level data
Other
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28072712
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29764380