HyperthyroidismMOTHYRENCT03951532
Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism
An observational study of Hyperthyroidism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Hyperthyroidism
- How many people
- 1,650 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes all children and adolescents (6 months -17 years included) whose data are present in the SNIIRAM database (DCIR data) and beneficiaries of the general health insurance scheme during the study period (01/01/2006-31/12/2017).
Who may be able to join
- children from 6 months to 17 years old included,
- who received a dispensation of synthetic antithyroid drugs during the study period.
Who cannot join
- infants under 6 months of age,
- beneficiaries belonging to social security schemes other than the general scheme,
- children from multiple pregnancies.
Trial locations and contacts
1 site in 1 country.
About this study
"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.
Read the 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.
- Conditions
- Hyperthyroidism
- Keywords
- Hyperthyroidism, paediatrics, health data base
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with hyperthyroidism | children and adolescents (6 months -17 years included) whose data are present in the SNIIRAM database (DCIR data) and beneficiaries of the general health insurance scheme during the study period (01/01/2006-31/12/2017) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of complications morbidity
number of complications morbidity associated with the three management modalities (treatment with synthetic antithyroid drugs (ATS), radioactive iodine and thyroidectomy) of children followed for Maladie de Basedow in France, over a period of 11 years.
Measured: for 11 years
number of complications mortality
number of complications morbidity associated with the three management modalities (treatment with synthetic antithyroid drugs (ATS), radioactive iodine and thyroidectomy) of children followed for Maladie de Basedow in France, over a period of 11 years.
Measured: for 11 years
Secondary outcomes (3)
number of children and adolescents with a prescription or therapeutic modalities
description of the therapeutic modalities of children and adolescents with Basedow's disease according to geographical distribution and time in France over a period of 11 years.
Measured: for 11 years
number of children with hyperthyroidism by geographical region and time in France
Estimation of the prevalence and incidence of hyperthyroidism in children by geographical region and time in France over a period of 11 years
Measured: for 11 years
number of hyperthyroidism associated with other comorbidities
Estimate of the number of hyperthyroidism associated with other co-morbidities, in particular cardiovascular disease, psychiatric disorders and cancer, in children according to geographical region and time in France over a period of 11 years.
Measured: for 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951532
- Sponsor's protocol ID
- NI16010HLJ
- Acronym
- MOTHYRE
- Status last verified
- Feb 2021
- First submitted
- 12 Mar 2019
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Moal J, Chesneau J, Goria S, Boizeau P, Haignere J, Kaguelidou F, Leger J. Spatiotemporal variation of childhood hyperthyroidism: a 10-year nationwide study. Eur J Endocrinol. 2022 Oct 3;187(5):675-683. doi: 10.1530/EJE-22-0355. Print 2022 Nov 1.
PubMed 36074933
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity and Mortality Associated With the Care Journey in Children and Adolescents With Hyperthyroidism
- ClinicalTrials.gov ID
- NCT03951532
- Acronym / sponsor ID
- MOTHYRE / NI16010HLJ
- Conditions
- Hyperthyroidism
- Keywords
- Hyperthyroidism, paediatrics, health data base
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with hyperthyroidism | – | –children and adolescents (6 months -17 years included) whose data are present in the SNIIRAM database (DCIR data) and beneficiaries of the general health insurance scheme during the study period (01/01/2006-31/12/2017) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes all children and adolescents (6 months -17 years included) whose data are present in the SNIIRAM database (DCIR data) and beneficiaries of the general health insurance scheme during the study period (01/01/2006-31/12/2017).
Key inclusion criteria (2 listed)
- children from 6 months to 17 years old included,
- who received a dispensation of synthetic antithyroid drugs during the study period.
Key exclusion criteria (3 listed)
- infants under 6 months of age,
- beneficiaries belonging to social security schemes other than the general scheme,
- children from multiple pregnancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of complications morbidity
Time frame: for 11 years
number of complications morbidity associated with the three management modalities (treatment with synthetic antithyroid drugs (ATS), radioactive iodine and thyroidectomy) of children followed for Maladie de Basedow in France, over a period of 11 years.
number of complications mortality
Time frame: for 11 years
number of complications morbidity associated with the three management modalities (treatment with synthetic antithyroid drugs (ATS), radioactive iodine and thyroidectomy) of children followed for Maladie de Basedow in France, over a period of 11 years.
3 secondary outcomes
number of children and adolescents with a prescription or therapeutic modalities
Time frame: for 11 years
number of children with hyperthyroidism by geographical region and time in France
Time frame: for 11 years
number of hyperthyroidism associated with other comorbidities
Time frame: for 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Results publication: PubMed 36074933Le Moal J, Chesneau J, Goria S, Boizeau P, Haignere J, Kaguelidou F, Leger J. Spatiotemporal variation of childhood hyperthyroidism: a 10-year nationwide study. Eur J Endocrinol. 2022 Oct 3;187(5):675-683. doi: 10.1530/EJE-22-0355. Print 2022 Nov 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of complications morbidity (time frame: for 11 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.