Thyroid DysfunctionNCT07900334
Study of Thyroid Dysfunction in Immune Thrombocytopenic Purpura Patients
An observational study of Thyroid Dysfunction and Immune Thrombocytopenic Purpura, run by Sohag University at 1 site in Egypt.
Trial summary
Study of relation between thyroid dysfunction and immune thrombocytopenic purpura patients and if there is relation between them Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thyroid Dysfunction, Immune Thrombocytopenic Purpura
- What is being tested?
- Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodies
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2026to 30 Sep 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will be conducted at Sohag university hospital as a case control study * Group 1:- Patients: available number of ITP patients. * Group 2 :- (control group): -Apparently healthy subjects with age and sex matching
Who may be able to join
- 1. Patient newly diagnosed immune thrombocytopenia.
- 2- No current thyroid therapy.
- 3-Able to provide informed consent and required clinical data (age, sex, ITP duration/therapy, bleeding history
Who cannot join
- 1. Known thyroid disease or prior thyroid therapy:
- Prior thyroidectomy, radioiodine, antithyroid drugs, or levothyroxine
- 2. Acute or critical illness within the past 4-6 weeks (non-thyroidal illness syndrome)
- ICU admission, major surgery, severe infection/trauma
- 3. Medications that acutely suppress or distort TSH around sampling
- High-dose glucocorticoids, dopamine/dobutamine infusions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Thyroid Dysfunction in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital
Study of relation between thyroid dysfunction and immune thrombocytopenic purpura patients and if there is relation between them
- Being tested
- Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodies
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodiesDiagnostic test
- Samples will be collected from patients newly diagnosed ITP from outpatient clinic in Sohag university hospital and all patients subjected to:
- Full history taking (age, duration of the disease)
- Clinical examination
- Complete blood count (CBC).
- Bone marrow aspiration:- (for patients with thrombocytopenia). 3-Thyroid work up :
- thyroid stimulating hormone (TSH)
- fT4, fT3
- Anti-Thyroid Peroxidase Antibodies (Anti TPO-Ab)
- Anti-Thyroglobulin Antibodies (Anti-TG-Ab)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Immune Thrombocytopenia (ITP) | Patients newly diagnosed with immune thrombocytopenia (ITP) who meet the study eligibility criteria. Participants will undergo clinical assessment, complete blood count (CBC), and thyroid function testing, including thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), anti-thyroid peroxidase antibodies (Anti-TPO), and anti-thyroglobulin antibodies (Anti-TG). Receives: Diagnostic Test: Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodies | |
| Healthy Control Group | Apparently healthy individuals matched to the patients with immune thrombocytopenia (ITP) for age and sex. Participants will undergo thyroid function testing, including thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), anti-thyroid peroxidase antibodies (Anti-TPO), and anti-thyroglobulin antibodies (Anti-TG). Receives: Diagnostic Test: Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of thyroid dysfunction in patients with immune thrombocytopenia (ITP)
The prevalence of thyroid dysfunction among patients with newly diagnosed immune thrombocytopenia (ITP) will be assessed using serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels. Thyroid function will be classified according to the laboratory reference ranges. The number and percentage of patients with abnormal thyroid function will be reported.
Measured: At baseline, during the initial study assessment.
Secondary outcomes (2)
Comparison of serum thyroid function test levels between patients with ITP and healthy controls
Serum TSH, FT3, and FT4 levels will be measured and compared between patients with newly diagnosed immune thrombocytopenia (ITP) and age- and sex-matched healthy controls. Results will be summarized using appropriate descriptive statistics.
Measured: At baseline, during the initial study assessment.
Prevalence of thyroid autoantibody positivity in patients with ITP and healthy controls
Serum anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-TG) will be measured in both study groups. The number and percentage of participants with positive thyroid autoantibodies will be determined according to the laboratory-specific reference ranges and compared between patients with ITP and healthy controls.
Measured: At baseline, during the initial study assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies of the same condition, open and under way.
- More trials run by Sohag 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Mahmoud Abdallah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900334
- Sponsor's protocol ID
- Soh-Med-26-7-18MS
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thyroid Dysfunction in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT07900334
- Acronym / sponsor ID
- Soh-Med-26-7-18MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Oct 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.
Study of relation between thyroid dysfunction and immune thrombocytopenic purpura patients and if there is relation between them
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Immune Thrombocytopenia (ITP) | – | Diagnostic Test: Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodiesPatients newly diagnosed with immune thrombocytopenia (ITP) who meet the study eligibility criteria. Participants will undergo clinical assessment, complete blood count (CBC), and thyroid function testing, including thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), anti-thyroid peroxidase antibodies (Anti-TPO), and anti-thyroglobulin antibodies (Anti-TG). |
| Healthy Control Group | – | Diagnostic Test: Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodiesApparently healthy individuals matched to the patients with immune thrombocytopenia (ITP) for age and sex. Participants will undergo thyroid function testing, including thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), anti-thyroid peroxidase antibodies (Anti-TPO), and anti-thyroglobulin antibodies (Anti-TG). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted at Sohag university hospital as a case control study * Group 1:- Patients: available number of ITP patients. * Group 2 :- (control group): -Apparently healthy subjects with age and sex matching
Key inclusion criteria (3 listed)
- 1. Patient newly diagnosed immune thrombocytopenia.
- 2- No current thyroid therapy.
- 3-Able to provide informed consent and required clinical data (age, sex, ITP duration/therapy, bleeding history
Key exclusion criteria (6 listed)
- 1. Known thyroid disease or prior thyroid therapy:
- 2. Acute or critical illness within the past 4-6 weeks (non-thyroidal illness syndrome)
- 3. Medications that acutely suppress or distort TSH around sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory tests TSH, FT3, FT4 ,anti thyroglobulin antibodies, Anti -TPO antibodies* Samples will be collected from patients newly diagnosed ITP from outpatient clinic in Sohag university hospital and all patients subjected to: 1. Full history taking (age, duration of the disease) 2. Clinical examination 3. Complete blood count (CBC). 4. Bone marrow aspiration:- (for patients with thrombocytopenia). 3-Thyroid work up : * thyroid stimulating hormone (TSH) * fT4, fT3 * Anti-Thyroid Peroxidase Antibodies (Anti TPO-Ab) * Anti-Thyroglobulin Antibodies (Anti-TG-Ab) | Diagnostic test | Healthy Control Group, Patients with Immune Thrombocytopenia (ITP) |
Primary outcome
Prevalence of thyroid dysfunction in patients with immune thrombocytopenia (ITP)
Time frame: At baseline, during the initial study assessment.
The prevalence of thyroid dysfunction among patients with newly diagnosed immune thrombocytopenia (ITP) will be assessed using serum thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels. Thyroid function will be classified according to the laboratory reference ranges. The number and percentage of patients with abnormal thyroid function will be reported.
2 secondary outcomes
Comparison of serum thyroid function test levels between patients with ITP and healthy controls
Time frame: At baseline, during the initial study assessment.
Prevalence of thyroid autoantibody positivity in patients with ITP and healthy controls
Time frame: At baseline, during the initial study assessment.
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 28 Oct 2026.
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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.
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 Thyroid Dysfunction and Immune Thrombocytopenic Purpura, run by Sohag University at 1 site in Egypt.
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 6 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 28 Oct 2026. 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 Egypt. 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?
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 Merna Mahmoud Abdallah, Resident (+2001044800511, mernaeltaib17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of thyroid dysfunction in patients with immune thrombocytopenia (ITP) (time frame: At baseline, during the initial study assessment.). 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 28 Oct 2026.