GoiterNCT03202160
Causes of Goiter in Children Attending Assiut University Children Hospital
An observational study of Goiter, run by Assiut University.
Trial summary
Thyroid disorders are one of the most common endocrine problems in children and adolescents. Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have normal function of the gland… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Goiter
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2018to 15 Sep 2019
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All cases of goiter attending Assiut University hospitals of ages since birth up to 18 years old in the period of study
Who may be able to join
- Children of both sexes of ages since birth up to 18 years old who are presented by goiter.
Who cannot join
- Any patient with neck swelling other than goiter.
- Refusal of participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cases of Goiter in Children Attending Assiut University Children Hospital
Thyroid disorders are one of the most common endocrine problems in children and adolescents. Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have normal function of the gland (euthyroidism), thyroid deficiency (hypothyroidism), or overproduction of the hormones (hyperthyroidism).
Read the detailed description
Congenital goiter most commonly occurs in neonates born to mothers with known thyroid disease especially Graves' disease. Other causes of congenital goitrous hypothyroidism are thyroid dyshormonogenesis, endemic iodine deficiency and maternal goitrogen ingestion or iodine excess (expectorants, povidone iodine).
The most common causes of euthyroid goiter in childhood are chronic lymphocytic thyroiditis and a colloid goiter (simple goiter). Thyroid enlargement that is not caused by inflammatory, infectious or neoplastic causes is termed a colloid goiter, also.
Chronic lymphocytic thyroiditis , also known as Hashimoto thyroiditis, is an autoimmune, inflammatory process that causes up to 55% to 65% of all euthyroid goiters, and almost all cases of thyroiditis in childhood and adolescence. A large North American prevalence study showed that as many as 1.2% of children aged 11 to18 years have chronic lymphocytic thyroiditis, as defined by an enlarged thyroid gland and detectable serum thyroid antibodies.
Thyroid nodules are relatively common in adolescents; these nodules are usually asymptomatic and often discovered incidentally, but they raise the fear of cancer. A multi-nodular goiter is almost invariably caused by Hashimoto's thyroiditis and it carries a good prognosis. The asymptomatic, solitary thyroid nodule is a thyroid adenoma, thyroid carcinoma or a thyroid cyst. Thyroid carcinoma occurs in approximately one per one million persons/year in the first-two decades of life.
No reported data are found as regard of causes of goiter in children in our locality.
- Conditions
- Goiter
- Keywords
- Goiter
- Medical subject headings
- Goiter
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum T3 and T4
Serum T3 and T4 for diagnosis of cause of goiter
Measured: 1 day
Neck ultrasonography
Neck ultrasonography for confirmation of diagnosis of goiter and for diagnosis of cause of goiter
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start15 Apr 2018 (estimated)
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
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 GoiterStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAAta, Assiut University
- Investigators
- Hanaa A Mohammed, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202160
- Sponsor's protocol ID
- CGCA
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muirhead S. Diagnostic approach to goitre in children. Paediatr Child Health. 2001 Apr;6(4):195-9. doi: 10.1093/pch/6.4.195.
PubMed 20084235
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cases of Goiter in Children Attending Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT03202160
- Acronym / sponsor ID
- CGCA
- Conditions
- Goiter
- Keywords
- Goiter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 28 Jun 2017 (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.
Thyroid disorders are one of the most common endocrine problems in children and adolescents. Diagnostic considerations can be approached from the perspective of the goiter.A goiter, or thyromegaly, is an enlargement of the thyroid gland.Persons with enlarged thyroids can have normal function of the gland (euthyroidism), thyroid deficiency (hypothyroidism), or overproduction of the hormones (hyperthyroidism).
Detailed description
Congenital goiter most commonly occurs in neonates born to mothers with known thyroid disease especially Graves' disease. Other causes of congenital goitrous hypothyroidism are thyroid dyshormonogenesis, endemic iodine deficiency and maternal goitrogen ingestion or iodine excess (expectorants, povidone iodine).
The most common causes of euthyroid goiter in childhood are chronic lymphocytic thyroiditis and a colloid goiter (simple goiter). Thyroid enlargement that is not caused by inflammatory, infectious or neoplastic causes is termed a colloid goiter, also.
Chronic lymphocytic thyroiditis , also known as Hashimoto thyroiditis, is an autoimmune, inflammatory process that causes up to 55% to 65% of all euthyroid goiters, and almost all cases of thyroiditis in childhood and adolescence. A large North American prevalence study showed that as many as 1.2% of children aged 11 to18 years have chronic lymphocytic thyroiditis, as defined by an enlarged thyroid gland and detectable serum thyroid antibodies.
Thyroid nodules are relatively common in adolescents; these nodules are usually asymptomatic and often discovered incidentally, but they raise the fear of cancer. A multi-nodular goiter is almost invariably caused by Hashimoto's thyroiditis and it carries a good prognosis. The asymptomatic, solitary thyroid nodule is a thyroid adenoma, thyroid carcinoma or a thyroid cyst. Thyroid carcinoma occurs in approximately one per one million persons/year in the first-two decades of life.
No reported data are found as regard of causes of goiter in children in our locality.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All cases of goiter attending Assiut University hospitals of ages since birth up to 18 years old in the period of study
Key inclusion criteria (1 listed)
- Children of both sexes of ages since birth up to 18 years old who are presented by goiter.
Key exclusion criteria (2 listed)
- Any patient with neck swelling other than goiter.
- Refusal of participation.
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
Serum T3 and T4
Time frame: 1 day
Serum T3 and T4 for diagnosis of cause of goiter
Neck ultrasonography
Time frame: 1 day
Neck ultrasonography for confirmation of diagnosis of goiter and for diagnosis of cause of goiter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Background: PubMed 20084235Muirhead S. Diagnostic approach to goitre in children. Paediatr Child Health. 2001 Apr;6(4):195-9. doi: 10.1093/pch/6.4.195.
- Individual participant dataSharing planned: No
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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.
Hanaa A Mohammed, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Goiter, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanaa A Mohammed, MD (00201120096055 ext. Assiut, hae50@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum T3 and T4 (time frame: 1 day). 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 NCT03202160, 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 28 Jun 2017.