Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03162159
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2017-05-11
Brief Title:
Adult Height Prediction in Congenital Adrenal Hyperplasia
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
An Adult Height Prediction Model for Congenital Adrenal Hyperplasia From a National Cohort OPALE Model Study
Status:
COMPLETED
Status Verified Date:
2020-08
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:
OPALE Model
Brief Summary:
Congenital Adrenal Hyperplasia CAH is a genetic rare disease which alters the adrenal production of gluco and mineralo corticoïds The treatment consists in supplementing children with hydrocortisone Despite care for these children has improved substantially across decades short adult height AH still remains an important consequence of the disease About 20 of patients have an AH below 2 standard deviations compared to their expected AH
In the OPALE-Model study the investigators want to collect data from a cohort of 496 CAH French patients born between 1970 and 1991 with a known genotype Using their age sex growth disease bone maturation and pubertal data the investigators will build a model which allows to predict their AH using data available at 8 years of age The growth charts built from this cohort have shown that currently used formula to calculate the predicted AH Bayley-Pineaus formula is not applicable to children with CAH
In this project the investigators plan to compute an AH prediction model using data from children born between 1970 and 1993 and to validate the model using data from a different cohort ie children born between 1994 and 1998 this choice was due to availability of data for computing the model first and in a second stage data from more recently born patients
In the OPALE-Model study the investigators want to collect data from a cohort of 496 CAH French patients born between 1970 and 1991 with a known genotype Using their age sex growth disease bone maturation and pubertal data the investigators will build a model which allows to predict their AH using data available at 8 years of age The growth charts built from this cohort have shown that currently used formula to calculate the predicted AH Bayley-Pineaus formula is not applicable to children with CAH
In this project the investigators plan to compute an AH prediction model using data from children born between 1970 and 1993 and to validate the model using data from a different cohort ie children born between 1994 and 1998 this choice was due to availability of data for computing the model first and in a second stage data from more recently born patients
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