Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-27 @ 10:44 AM
Study NCT ID:
NCT03951532
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism
Status:
COMPLETED
Status Verified Date:
2021-02
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:
MOTHYRE
Brief Summary:
"Early paediatric Basedow disease is one of the rare endocrine diseases for which the Reference Centre for Rare Endocrine Growth Diseases, was approved by the Ministry of Health in 2005. In addition, the study will benefit from the expertise of public Health France (SFP). This study is therefore part of the missions of these partners (reference centre for endocrine growth diseases and Public Health France).
For several years, our group has been interested in defining the evolutionary profile of these patients. A national study on short- and long-term patient follow-up has already been conducted, which has been the subject of two international publications29,30, as well as a study on a specific clinical form of the disease 24. This work was made possible thanks to the collaboration of paediatric clinical centres within the Reference Centre and Competence Centre for Rare Endocrine Diseases Network. The present study planned in France will make it possible to accurately characterize the care pathway and the frequency of complications associated with it at the national level.
For several years, our group has been interested in defining the evolutionary profile of these patients. A national study on short- and long-term patient follow-up has already been conducted, which has been the subject of two international publications29,30, as well as a study on a specific clinical form of the disease 24. This work was made possible thanks to the collaboration of paediatric clinical centres within the Reference Centre and Competence Centre for Rare Endocrine Diseases Network. The present study planned in France will make it possible to accurately characterize the care pathway and the frequency of complications associated with it at the national level.
Detailed Description:
"With regard to the analysis of data on the identification of hyperthyroidism in children using the various medico-administrative databases, the epidemiological study of hyperthyroidism in children in France seems feasible using data on drug consumption from the SNIIRAM. These data will make it possible for the first time to study the impact of the disease in terms of serious morbidity and mortality (related to the disease and/or treatment) and to make recommendations for the management of the disease in order to improve the prognosis of the disease in children.
Thanks to these results, incidence data on the disease in children will be able to be estimated for the first time in France, as well as its temporal and spatial trends. They will be compared with national studies carried out in Sweden, Denmark and the United Kingdom on children. The spatial distribution in France can also be studied and compared with existing or emerging hypotheses, in particular concerning endocrine disrupters (French public health data). These analyses could also allow the generation of new causal hypotheses.
Finally, this work could lead to the establishment of national surveillance of hyperthyroidism in children. Prolonged follow-up is necessary, even after the end of medical treatment or after radical treatment, to determine the effectiveness of the management of patients during childhood and the impact on their overall health.
This study should therefore make it possible to propose recommendations to optimize the therapeutic management of hyperthyroidism in children and adolescents and improve the quality of life in adulthood for these patients.
The main objective of the study is to describe the complications (morbidity and mortality) associated with the 3 management modalities (treatment with synthetic antithyroid drugs (ATS), radioactive iodine and thyroidectomy) of children followed for hyperthyroidism in France, over a period of 11 years.
The study design chosen is that of an observational historical cohort study based on medico-administrative data from the National Inter-Regime Health Insurance Information System (SNIIRAM), which contains data from the PMSI (Information Systems Medicalization Program).
The study period begins on 01.01.2006 and ends on 31.12.2017.
Thanks to these results, incidence data on the disease in children will be able to be estimated for the first time in France, as well as its temporal and spatial trends. They will be compared with national studies carried out in Sweden, Denmark and the United Kingdom on children. The spatial distribution in France can also be studied and compared with existing or emerging hypotheses, in particular concerning endocrine disrupters (French public health data). These analyses could also allow the generation of new causal hypotheses.
Finally, this work could lead to the establishment of national surveillance of hyperthyroidism in children. Prolonged follow-up is necessary, even after the end of medical treatment or after radical treatment, to determine the effectiveness of the management of patients during childhood and the impact on their overall health.
This study should therefore make it possible to propose recommendations to optimize the therapeutic management of hyperthyroidism in children and adolescents and improve the quality of life in adulthood for these patients.
The main objective of the study is to describe the complications (morbidity and mortality) associated with the 3 management modalities (treatment with synthetic antithyroid drugs (ATS), radioactive iodine and thyroidectomy) of children followed for hyperthyroidism in France, over a period of 11 years.
The study design chosen is that of an observational historical cohort study based on medico-administrative data from the National Inter-Regime Health Insurance Information System (SNIIRAM), which contains data from the PMSI (Information Systems Medicalization Program).
The study period begins on 01.01.2006 and ends on 31.12.2017.
Study Oversight
Has Oversight DMC:
False
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?: