Establishment of Reference Values for Insulin-like Growth Factor 1 (IGF1) in the General Population (VARIETE)
Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each assay gives a very different result for the same sample. As IGF-I also varies with age, it is necessary to establish a broad population reference values of IGF1 concentration for each of the IGF1 assays used in clinical practice, taking into account individual variation factors such as age, nutritional status and possible treatments.
The objective of this study is to establish normative data based on a large random selection from the general population, including representation from all age groups (around 100 subjects for each decade age range). This will be performed for all the available assay kits. Subjects with medical conditions and medications that may affect the outcome will be excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and results will be reported as mass units but also as SD scores in order to be able, in a given patient, to compare its IGF-I concentration along time, even if using different assays.
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||An Open, Prospective, National, Multicenter, Non Randomised, Study Based on Healthy Volunteers for Establishing Normative Data for IGF1 in the General Population|
- Concentration of IGF1 in serum [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]Establishment of reference values for the concentration of IGF1 in the general adult population for each of the assays of IGF1 used in clinical practice, taking into account individual variation factors such as age, nutritional status and potential treatments.
- Development of an expression results in Z-score for all assays to overcome the differences related to different immunoassays. [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
- Establishment of a bank of frozen sera to further develop these standards [ Time Frame: up to 4 hours ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Healthy subjects will be recruited in 30 centers all around France. A total of 1000 healthy subjects are necessary. Each subject will have a clinical examination with measurement of height and weight. Personal medical history will be recorded and gonadal status evaluated. Biological standard workup will be performed and 80 ml of blood will be sampled and serum will be aliquoted, frozen and stored at -80°C. IGF-I level will be measured with all the assay methods available (sera kept in bank will be used in the future when new methods will be available) For each assay method and each age group (Four 3-years groups between 18 and 30 years and six decade age groups between 30 and 89 years) IGF-I will be measured.
Results will be expressed as mean, median, standard deviation, 2.5th and 97.5th percentiles, in mass units. Modelisation according to age and other factors will be performed in order to allow the reporting of IGF-I results for a given individual expression of IGF-I as Z-score.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01831648
|Assistance Publique - Hôpitaux de Paris|
|Le KREMLIN-BICETRE, France, 94 275|
|Principal Investigator:||Philippe CHANSON, Professor||Assistance Publique Hôpitaux de Paris - Bicêtre Hospital|