Hashimoto's ThyroiditisNCT06603415
Hashimoto's Thyroiditis in Upper Egypt
A study testing Total thyroidectomy in people with Hashimoto's Thyroiditis, run by Sohag University at 2 sites in Egypt.
Trial summary
The aim of this study is to evaluate the pathological pattern, characteristic features, treatment, complications and prognosis of Hashimoto's thyroiditis in upper Egypt. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hashimoto's Thyroiditis
- What is being tested?
- Total thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with Hashimoto's thyroiditis, males or females, any age, at upper egypt .
Who cannot join
- Patients with associated other thyroid pathology other than Hashimoto's thyroiditis.
Trial locations and contacts
2 sites in 1 country.
Kamal A Mohamed, Professor contact
Egypt2 sites, 2 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor, 01090801900
- Recruiting
Sohag university hospital
Sohag
Hossam M A, Resident, +201158973535, Hossam.araby07@gamil.com
About this study
Official title: Pattern of Hashimoto's Thyroiditis in Upper Egypt
The aim of this study is to evaluate the pathological pattern, characteristic features, treatment, complications and prognosis of Hashimoto's thyroiditis in upper Egypt.
- Conditions
- Hashimoto's Thyroiditis
- Being tested
- Total thyroidectomy
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
Total thyroidectomy (with preservation of bilateral recurrent laryngeal nerves and all parathroid glands) for histopathology
| Study group | Role | What they receive |
|---|---|---|
| PATTERN OF HASHIMOTO'S THYROIDITIS IN UPPER EGYPT | Other | the pathological pattern, characteristics, treatment, complications and prognosis of Hashimoto's thyroiditis in upper egypt . Receives: Procedure: Total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early post operative follow up of Hashimoto's thyroiditis
Removal of suction drains
Measured: 3 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (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 Hashimoto's ThyroiditisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mohamed Araby, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603415
- Sponsor's protocol ID
- Soh-Med-24-07-06MS
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feldt-Rasmussen U. Hashimoto's thyroiditis as a risk factor for thyroid cancer. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):364-371. doi: 10.1097/MED.0000000000000570.
PubMed 32773575Cipolla C, Sandonato L, Graceffa G, Fricano S, Torcivia A, Vieni S, Latteri S, Latteri MA. Hashimoto thyroiditis coexistent with papillary thyroid carcinoma. Am Surg. 2005 Oct;71(10):874-8.
PubMed 16468540Kashima K, Yokoyama S, Noguchi S, Murakami N, Yamashita H, Watanabe S, Uchino S, Toda M, Sasaki A, Daa T, Nakayama I. Chronic thyroiditis as a favorable prognostic factor in papillary thyroid carcinoma. Thyroid. 1998 Mar;8(3):197-202. doi: 10.1089/thy.1998.8.197.
PubMed 9545105
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Hashimoto's Thyroiditis in Upper Egypt
- ClinicalTrials.gov ID
- NCT06603415
- Acronym / sponsor ID
- Soh-Med-24-07-06MS
- Conditions
- Hashimoto's Thyroiditis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Sep 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.
The aim of this study is to evaluate the pathological pattern, characteristic features, treatment, complications and prognosis of Hashimoto's thyroiditis in upper Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATTERN OF HASHIMOTO'S THYROIDITIS IN UPPER EGYPT | Other | Procedure: Total thyroidectomythe pathological pattern, characteristics, treatment, complications and prognosis of Hashimoto's thyroiditis in upper egypt . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with Hashimoto's thyroiditis, males or females, any age, at upper egypt .
Key exclusion criteria (1 listed)
- Patients with associated other thyroid pathology other than Hashimoto's thyroiditis.
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 |
|---|---|---|
| Total thyroidectomyTotal thyroidectomy (with preservation of bilateral recurrent laryngeal nerves and all parathroid glands) for histopathology | Procedure or surgery | PATTERN OF HASHIMOTO'S THYROIDITIS IN UPPER EGYPT |
Primary outcome
Early post operative follow up of Hashimoto's thyroiditis
Time frame: 3 days after the operation
Removal of suction drains
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 32773575Feldt-Rasmussen U. Hashimoto's thyroiditis as a risk factor for thyroid cancer. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):364-371. doi: 10.1097/MED.0000000000000570.
- Background: PubMed 16468540Cipolla C, Sandonato L, Graceffa G, Fricano S, Torcivia A, Vieni S, Latteri S, Latteri MA. Hashimoto thyroiditis coexistent with papillary thyroid carcinoma. Am Surg. 2005 Oct;71(10):874-8.
- Background: PubMed 9545105Kashima K, Yokoyama S, Noguchi S, Murakami N, Yamashita H, Watanabe S, Uchino S, Toda M, Sasaki A, Daa T, Nakayama I. Chronic thyroiditis as a favorable prognostic factor in papillary thyroid carcinoma. Thyroid. 1998 Mar;8(3):197-202. doi: 10.1089/thy.1998.8.197.
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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.
Kamal A Mohamed, Professor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy in people with Hashimoto's Thyroiditis, run by Sohag University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam M Araby, Resident (+201158973535, hossam.araby07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early post operative follow up of Hashimoto's thyroiditis (time frame: 3 days after the operation). 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 NCT06603415, 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 19 Sep 2024.