Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03748407
Status:
UNKNOWN
Last Update Posted:
2018-11-20
First Post:
2018-10-30
Brief Title:
Determination of Baseline Thyroid Status Values in French Adult Population
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Determination of Baseline Thyroid Status Values
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
NOT_YET_RECRUITING
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:
THYRBECK
Brief Summary:
The objective of this study is to establish reference values in the general population from a Beckman Coulter DxI chemiluminescence assay
Indeed the lack of harmonization of the methods of the dosage remains a major difficulty to optimize the management of patients with thyroid disease
This supplier has recently optimized its dosing kit according to the 3rd international standard of the WHO IRB 81565 for the TSH Thyroid Stimulating Hormon
It is necessary to carry out a study of the distribution of the values of this TSH within our metropolitan population The current data proposed by the supplier come from a study of a North American population
investigators propose to define usual values for thyroid status markers TSH FT4 free thyroxine FT3 free triiodothyroxine from healthy EFS French Blood Establishment donors who meet the standard exclusion criteria for this type of study
Indeed the lack of harmonization of the methods of the dosage remains a major difficulty to optimize the management of patients with thyroid disease
This supplier has recently optimized its dosing kit according to the 3rd international standard of the WHO IRB 81565 for the TSH Thyroid Stimulating Hormon
It is necessary to carry out a study of the distribution of the values of this TSH within our metropolitan population The current data proposed by the supplier come from a study of a North American population
investigators propose to define usual values for thyroid status markers TSH FT4 free thyroxine FT3 free triiodothyroxine from healthy EFS French Blood Establishment donors who meet the standard exclusion criteria for this type of study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None