Condition category
Not Applicable
Date applied
23/05/2015
Date assigned
27/05/2015
Last edited
27/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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?
The study received a major grant from the INOVA Foundation in Vaduz, Liechtenstein.

Who is the main contact?
Dr.Martin Risch, martin.risch@ksgr.ch
Dr. Lorenz Risch, lorenz.risch@risch.ch

Trial website

http://www.seniorlabor.ch

Contact information

Type

Scientific

Primary contact

Dr.med. Martin Risch

ORCID ID

Contact details

Kantonsspital Graubünden
Zentrallabor
Loësstrasse 170
Chur
7000
Switzerland

Type

Public

Additional contact

PD Dr.med. 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 measures

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

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

Sponsor information

Organisation

Labormedizinisches Zentrum Dr. Risch

Sponsor details

Waldeggstrasse 37
Liebefeld
3097
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

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:
- Publications of cross-sectional analyses are ongoing since 2012
- The method paper of the prospective study will be submitted in June 2015
- Publication of reference intervals will be continuously submitted starting from the second half 2015
- Longitudinal analyses will be continuously published beginning 2017

Intention to publish date

31/12/2015

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes