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Not yet recruitingNCT07858097Updated Oct 5, 2026

Bethesda Classification and Risk Stratification in Differentiated Thyroid Carcinoma

An observational study in Differentiated Thyroid Carcinoma, Papillary Thyroid Carcinoma and Follicular Thyroid Carcinoma, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Assiut University · Observational

Updated Oct 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

This observational study aims to evaluate the relationship between preoperative Bethesda classification of fine-needle aspiration cytology and postoperative American Thyroid Association (ATA) risk stratification in patients with differentiated thyroid carcinoma.

Read the detailed description

Differentiated thyroid carcinoma (DTC) accounts for the majority of thyroid cancers and generally has a favorable prognosis. The incidence of DTC has increased worldwide, largely due to improved detection of thyroid nodules with high-resolution ultrasonography and the widespread use of fine-needle aspiration cytology (FNAC).

The Bethesda System for Reporting Thyroid Cytopathology classifies thyroid cytology into six diagnostic categories, each associated with a specific risk of malignancy and recommended clinical management. While the Bethesda classification is useful for predicting the likelihood of malignancy, its relationship with postoperative prognosis and risk stratification remains less clear.

After thyroidectomy, patients are stratified according to the American Thyroid Association (ATA) risk stratification system into low-, intermediate-, and high-risk categories. Understanding the association between the preoperative Bethesda category and postoperative ATA risk stratification may improve early prognostic assessment and help optimize treatment and follow-up strategies.

This observational study will examine the relationship between preoperative Bethesda classification and postoperative ATA risk stratification in patients with histopathologically confirmed differentiated thyroid carcinoma.

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Conditions studied

  • Differentiated Thyroid Carcinoma
  • Papillary Thyroid Carcinoma
  • Follicular Thyroid Carcinoma

Keywords

  • Bethesda classification
  • Fine-needle aspiration cytology
  • FNAC
  • ATA risk stratification
  • Differentiated thyroid cancer
  • Thyroid nodules
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In context

Thyroid Cancer, Papillary

175 studies on the registry are indexed under Thyroid Cancer, Papillary; 52 are open to participants now.

This study's planned enrollment of 100 is below the median of 198 across 66 observational studies indexed under Thyroid Cancer, Papillary.

Browse Thyroid Cancer, Papillary studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with histopathologically confirmed differentiated thyroid carcinoma who underwent preoperative fine-needle aspiration cytology and are followed at the Nuclear Medicine Unit, Assiut University Hospitals.

Inclusion criteria

  • Age ≥ 18 years
  • Available preoperative fine-needle aspiration cytology (FNAC)
  • Postoperative histopathologically confirmed differentiated thyroid carcinoma

Exclusion criteria

Exclusion Criteria:

  • Poorly differentiated thyroid carcinoma
  • Anaplastic thyroid carcinoma
  • Medullary thyroid carcinoma
  • Non-diagnostic FNAC (Bethesda category I)
  • Inadequate follow-up data
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Patients with Differentiated Thyroid Carcinoma

    Adult patients with histopathologically confirmed differentiated thyroid carcinoma who underwent preoperative fine-needle aspiration cytology and are followed at the Nuclear Medicine Unit, Assiut University Hospitals.

06

What researchers measure

Primary outcomes

  1. Proportion of patients with high ATA risk stratification

    Proportion of patients classified as high risk according to the American Thyroid Association (ATA) risk stratification system.

    Time frame: At 1 month

Secondary outcomes

  1. Proportion of patients with papillary thyroid carcinoma subtype

    Proportion of patients with papillary thyroid carcinoma histopathological subtype.

    Time frame: Baseline

  2. Proportion of patients receiving radioactive iodine therapy

    Proportion of patients who received radioactive iodine (RAI) therapy.

    Time frame: At 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Kitahara CM, Sosa JA. The changing incidence of thyroid cancer. Nat Rev Endocrinol. 2016 Nov;12(11):646-653. doi: 10.1038/nrendo.2016.110. Epub 2016 Jul 15. PubMed 27418023 ↗
  • Bongiovanni M, Spitale A, Faquin WC, Mazzucchelli L, Baloch ZW. The Bethesda System for Reporting Thyroid Cytopathology: a meta-analysis. Acta Cytol. 2012;56(4):333-9. doi: 10.1159/000339959. Epub 2012 Jul 25. PubMed 22846422 ↗
  • Ali SZ, Baloch ZW, Cochand-Priollet B, Schmitt FC, Vielh P, VanderLaan PA. The 2023 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2023 Sep;33(9):1039-1044. doi: 10.1089/thy.2023.0141. Epub 2023 Jul 8. PubMed 37427847 ↗
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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07858097
Lead sponsor
Assiut University
Responsible party
Alia Mohamed Kenawy Rezk (Resident of Nuclear Medicine, Assiut University) — Principal investigator
First posted
Oct 5, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
Oct 25, 2027 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

Alia M Kenawy, resident
Contact
Aliaaliayyy@gmail.com
0 10 97551147 ext. 022
Taha M Zaky, prof
study chair · Nuclear Medicine Unit, Department of Clinical Oncology and Nuclear Medicine, Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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