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Thyroid NoduleNCT06417463

Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules

An observational study of Thyroid Nodule, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

role of TIRADS and Bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative FNA .that nodules are usually divided into diffent categories based on TIRADS and are then… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Thyroid Nodule
What is being tested?
thyroidectomy opeartion
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteEgypt
Study dates
12 May 2024to 12 Oct 2024
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: patients will proved to have single or multinodular goitre \& patients with thyroid nodules more than 1 cm

Who may be able to join

  • patients will proved to have single or multinodular goitre thyroid nodules more than 1cm

Who cannot join

  • thyroid nodules less than 1 cm history of thyroid surgery history of radiotherapy

Trial locations and contacts

1 site in 1 country.

kerloes N boulis, resident contact

01287533690

kerloesnagy@med.sohag.edu.eg

Egypt1 site, 1 recruiting

  • Sohag university Hospital

    Sohag

    Magdy M Amin, professor

    Recruiting

Other trials in Egypt

About this study

role of TIRADS and Bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative FNA .that nodules are usually divided into diffent categories based on TIRADS and are then referred to FNA and follow up according to variable risk of maligneny.

Read the detailed description

this study is an observational study will be conducted on patiend with thyroid nodules will be admitted to general surgical department at sohag university hospital . patients will be approved to have single or multinodular goitre and thyroid nodules more than 1 cm . thyroid nodules are very common disease with great clinical importance although most cases are benign and only 4.5% to 6.5% are malignant ... itis necessary to distinguish those cases to reduce frequency of unnecessary thyroidectomies ... ultrasound classification and Fine needle aspiration (FNA) are first line diagnostic procedures and help in decrease cases undergoing unnecessary thyroidectomies as 50% of the nodules removed recently are malignant and the number of patients undergoing surgery is significantly reduced.

Conditions
Thyroid Nodule
Being tested
thyroidectomy opeartion
Medical subject headings
Thyroid Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thyroidectomy opeartionProcedure or surgery

    correlation between TIRADS and Bethesda scoring system (preoperative) and final histopathology (postoperative) in cases of thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. managemnt thyroid nodules

    correlation between TIRADS and Behtesda scoring systems (preoperative) and final histopathology (post opeartive) in cases of thyroidectomy

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start12 May 2024 (estimated)
  3. Primary completion12 Oct 2024 (estimated)
  4. Study completion12 Oct 2024 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417463
Sponsor's protocol ID
Soh-Med-24-04-05MS
Status last verified
May 2024
First submitted
12 May 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • AlSaedi AH, Almalki DS, ElKady RM. Approach to Thyroid Nodules: Diagnosis and Treatment. Cureus. 2024 Jan 13;16(1):e52232. doi: 10.7759/cureus.52232. eCollection 2024 Jan.

    PubMed 38352091

  • Bojunga J, Trimboli P. Thyroid ultrasound and its ancillary techniques. Rev Endocr Metab Disord. 2024 Feb;25(1):161-173. doi: 10.1007/s11154-023-09841-1. Epub 2023 Nov 10.

    PubMed 37946091

  • Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500.

    PubMed 29091573

  • Pemayun TG. Current Diagnosis and Management of Thyroid Nodules. Acta Med Indones. 2016 Jul;48(3):247-257.

    PubMed 27840362

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Nodule, 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 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 16 May 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact kerloes N boulis, resident (01287533690, kerloesnagy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

managemnt thyroid nodules (time frame: 6 months). 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 NCT06417463, which also lists 4 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 16 May 2024.

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