Graves' DiseaseNCT06357494
Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease
An observational study of Graves' Disease, run by Assiut University.
Trial summary
All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Graves' Disease
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2024to 5 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children who will come at pediatric endocrinology outpatient clinic of Assiut University Children's Hospital meeting our inclusion criteria.
Who may be able to join
- All newly diagnosed children with clinical and laboratory hyperthyroidism (high T4 \& low TSH) with positive TRAbs.
Who cannot join
- Patients receiving radioiodine Patients underwent thyroid surgery History of neck radiation or neck surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Thyroid Doppler Ultrasound in Relation to Clinical and Laboratory Parameters in Follow up of Pediatric Graves' Disease
All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.
Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.
Read more
Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.
Doppler ultrasound will be done at 0, 12 and 24 months.
- Conditions
- Graves' Disease
- Medical subject headings
- Graves Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid volume
Measured: 3 years
number of vessels per square cm of thyroid gland
Measured: 2 years
inferior thyroid artery peak systolic velocity
Measured: 2 years
end diastolic velocity
Measured: 2 years
resistive index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start5 Aug 2024 (estimated)
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.L.Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357494
- Sponsor's protocol ID
- Thyroid Doppler in Graves'
- Status last verified
- Jul 2024
- First submitted
- 5 Apr 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Thyroid Doppler Ultrasound in Relation to Clinical and Laboratory Parameters in Follow up of Pediatric Graves' Disease
- ClinicalTrials.gov ID
- NCT06357494
- Acronym / sponsor ID
- Thyroid Doppler in Graves'
- Conditions
- Graves' Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (estimated)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2028 (estimated)
- First posted
- 10 Apr 2024 (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.
All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.
Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.
Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.
Doppler ultrasound will be done at 0, 12 and 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children who will come at pediatric endocrinology outpatient clinic of Assiut University Children's Hospital meeting our inclusion criteria.
Key inclusion criteria (1 listed)
- All newly diagnosed children with clinical and laboratory hyperthyroidism (high T4 \& low TSH) with positive TRAbs.
Key exclusion criteria (1 listed)
- Patients receiving radioiodine Patients underwent thyroid surgery History of neck radiation or neck surgery
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
thyroid volume
Time frame: 3 years
number of vessels per square cm of thyroid gland
Time frame: 2 years
inferior thyroid artery peak systolic velocity
Time frame: 2 years
end diastolic velocity
Time frame: 2 years
resistive index
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves' Disease, 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 1 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: opening soon, as of the sponsor's last update on 16 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanaa A Mohamad, Professor of pediatrics (01064747613, hae50@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid volume (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.