Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01831648
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2013-04-03
Brief Title:
Establishment of Reference Values for Insulin-like Growth Factor 1 IGF1 in the General Population
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
An Open Prospective National Multicenter Non Randomised Study Based on Healthy Volunteers for Establishing Normative Data for IGF1 in the General Population
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VARIETE
Brief Summary:
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 25 to 975 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
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 25 to 975 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
Detailed Description:
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 -80C 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 25th and 975th 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
Results will be expressed as mean median standard deviation 25th and 975th 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None