Thyroid DiseaseNCT07827235
Thyroid Disorders in Pediatric Autoimmune Hepatitis
An observational study of Thyroid Disease and Autoimmune Hepatitis, run by Assiut University.
Trial summary
This cross-sectional study aims to determine the frequency and spectrum of thyroid disorders among children with autoimmune hepatitis attending Assiut University Children's Hospital. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Thyroid Disease, Autoimmune Hepatitis, Hashimoto Thyroiditis
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 10 Feb 2028
- How long will I take part?
- 1 Day
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children less than 18 years diagnosed with autoimmune hepatitis attending the Pediatric Hepatology Unit and Outpatient Clinic at Assiut University Children's Hospital.
Who may be able to join
- Age less than 18 years
- Diagnosis of autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system
- Written informed consent from parents or legal guardians
Who cannot join
- - Previously diagnosed thyroid disorders before the diagnosis of autoimmune hepatitis
- Medications known to interfere with thyroid function tests (other than corticosteroids or immunosuppressive therapy for AIH)
- Chronic systemic diseases known to affect thyroid function independently of AIH
- Other autoimmune disorders (celiac disease, diabetes, inflammatory bowel disease)
- Refusal to participate
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: Frequency of Thyroid Disorders in Pediatric Patients With Autoimmune Hepatitis at Assiut University Children's Hospital
This cross-sectional study aims to determine the frequency and spectrum of thyroid disorders among children with autoimmune hepatitis attending Assiut University Children's Hospital.
Read the detailed description
Autoimmune hepatitis is frequently associated with other autoimmune disorders, particularly autoimmune thyroid diseases. Thyroid dysfunction in children may remain asymptomatic yet affect growth and development.
This observational study will include children less than 18 years diagnosed with autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system. All participants will undergo thyroid function tests (TSH, FT3, FT4), thyroid autoantibodies (anti-TPO, anti-Tg), and thyroid ultrasonography.
- Keywords
- Autoimmune hepatitis, Thyroid disorders, Anti-TPO, Pediatric, Assiut
- Medical subject headings
- Thyroid Diseases, Hepatitis, Autoimmune, Hashimoto Disease, Graves Disease
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 |
|---|---|---|
| Single cohort: Children with autoimmune hepatitis | Children less than 18 years with autoimmune hepatitis who will undergo thyroid function tests, thyroid autoantibodies, and thyroid ultrasonography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of thyroid disorders
Number of participants with autoimmune hepatitis who have any thyroid disorder including overt or subclinical hypothyroidism, hyperthyroidism, or autoimmune thyroiditis based on thyroid function tests, autoantibodies, and ultrasonography
Measured: Baseline
Secondary outcomes (6)
Pattern of thyroid disorders
Number of participants with specific thyroid disorders including Hashimoto thyroiditis, Graves disease, subclinical hypothyroidism, subclinical hyperthyroidism, and others
Measured: Baseline
Thyroid autoantibody positivity
Number of participants with positive anti-thyroid peroxidase and/or anti-thyroglobulin antibodies
Measured: Baseline
Thyroid ultrasonographic abnormalities
Proportion of children with abnormal thyroid ultrasound findings (enlargement, hypoechogenicity, nodules, or altered vascularity).
Measured: Baseline
Serum TSH level
Mean serum thyroid-stimulating hormone (TSH) level (µIU/mL).
Measured: Baseline
Serum free T4 level
Mean serum free thyroxine (FT4) level (ng/dL).
Measured: Baseline
Serum free T3 level
Mean serum free triiodothyronine (FT3) level (pg/mL).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Alaaeldin Mohamed Ahmed, Assiut University
- Investigators
- Amal A seliman, prof, Study chair, pediatrics Department, Assiut University HospitalsShereen M Galal, Prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827235
- Sponsor's protocol ID
- Thyroid-AIH-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mieli-Vergani G, Vergani D, Baumann U, Czubkowski P, Debray D, Dezsofi A, Fischler B, Gupte G, Hierro L, Indolfi G, Jahnel J, Smets F, Verkade HJ, Hadzic N. Diagnosis and Management of Pediatric Autoimmune Liver Disease: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):345-360. doi: 10.1097/MPG.0000000000001801.
PubMed 29356770Ijaz MK, Sattar SA, Boone SA, Nims RW, McKinney J, Gerba CP. Dynamics of respiratory virus spread indoors suggest a holistic approach for exposure risk mitigation. Antimicrob Steward Healthc Epidemiol. 2025 Oct 29;5(1):e289. doi: 10.1017/ash.2025.10147. eCollection 2025.
PubMed 41180295Chen M, Gu H, Xuan G, Ma L, Tu S, Li M. Elective neck dissection versus elective neck irradiation in cT3/4N0 maxillary sinus squamous cell carcinoma: a propensity score matching analysis. World J Surg Oncol. 2024 Apr 15;22(1):95. doi: 10.1186/s12957-024-03368-8.
PubMed 38622695
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Thyroid Disorders in Pediatric Patients With Autoimmune Hepatitis at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07827235
- Acronym / sponsor ID
- Thyroid-AIH-Assiut-2026
- Keywords
- Autoimmune hepatitis, Thyroid disorders, Anti-TPO, Pediatric, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 18 Sep 2026 (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.
This cross-sectional study aims to determine the frequency and spectrum of thyroid disorders among children with autoimmune hepatitis attending Assiut University Children's Hospital.
Detailed description
Autoimmune hepatitis is frequently associated with other autoimmune disorders, particularly autoimmune thyroid diseases. Thyroid dysfunction in children may remain asymptomatic yet affect growth and development.
This observational study will include children less than 18 years diagnosed with autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system. All participants will undergo thyroid function tests (TSH, FT3, FT4), thyroid autoantibodies (anti-TPO, anti-Tg), and thyroid ultrasonography.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Children with autoimmune hepatitis | – | –Children less than 18 years with autoimmune hepatitis who will undergo thyroid function tests, thyroid autoantibodies, and thyroid ultrasonography. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children less than 18 years diagnosed with autoimmune hepatitis attending the Pediatric Hepatology Unit and Outpatient Clinic at Assiut University Children's Hospital.
Key inclusion criteria (3 listed)
- Age less than 18 years
- Diagnosis of autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system
- Written informed consent from parents or legal guardians
Key exclusion criteria (5 listed)
- - Previously diagnosed thyroid disorders before the diagnosis of autoimmune hepatitis
- Medications known to interfere with thyroid function tests (other than corticosteroids or immunosuppressive therapy for AIH)
- Chronic systemic diseases known to affect thyroid function independently of AIH
- Other autoimmune disorders (celiac disease, diabetes, inflammatory bowel disease)
- Refusal to participate
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
Frequency of thyroid disorders
Time frame: Baseline
Number of participants with autoimmune hepatitis who have any thyroid disorder including overt or subclinical hypothyroidism, hyperthyroidism, or autoimmune thyroiditis based on thyroid function tests, autoantibodies, and ultrasonography
6 secondary outcomes
Pattern of thyroid disorders
Time frame: Baseline
Thyroid autoantibody positivity
Time frame: Baseline
Thyroid ultrasonographic abnormalities
Time frame: Baseline
Serum TSH level
Time frame: Baseline
Serum free T4 level
Time frame: Baseline
Serum free T3 level
Time frame: Baseline
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 22 Sep 2026.
- Background: PubMed 29356770Mieli-Vergani G, Vergani D, Baumann U, Czubkowski P, Debray D, Dezsofi A, Fischler B, Gupte G, Hierro L, Indolfi G, Jahnel J, Smets F, Verkade HJ, Hadzic N. Diagnosis and Management of Pediatric Autoimmune Liver Disease: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):345-360. doi: 10.1097/MPG.0000000000001801.
- Background: PubMed 41180295Ijaz MK, Sattar SA, Boone SA, Nims RW, McKinney J, Gerba CP. Dynamics of respiratory virus spread indoors suggest a holistic approach for exposure risk mitigation. Antimicrob Steward Healthc Epidemiol. 2025 Oct 29;5(1):e289. doi: 10.1017/ash.2025.10147. eCollection 2025.
- Background: PubMed 38622695Chen M, Gu H, Xuan G, Ma L, Tu S, Li M. Elective neck dissection versus elective neck irradiation in cT3/4N0 maxillary sinus squamous cell carcinoma: a propensity score matching analysis. World J Surg Oncol. 2024 Apr 15;22(1):95. doi: 10.1186/s12957-024-03368-8.
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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.
Amal A seliman, prof study chair
pediatrics Department, Assiut University Hospitals
Shereen M Galal, Prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease and Autoimmune Hepatitis, 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 3 inclusion and 5 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 22 Sep 2026. 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 Arwa M Mohamed, Resident (+20 10 26065202, Arwa.18313343@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of thyroid disorders (time frame: Baseline). 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 NCT07827235, which also lists 3 linked publications.
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 22 Sep 2026.