Differentiated Thyroid CarcinomaNCT07858097
Bethesda Classification and Risk Stratification in Differentiated Thyroid Carcinoma
An observational study of Differentiated Thyroid Carcinoma and Papillary Thyroid Carcinoma, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Carcinoma, Papillary Thyroid Carcinoma, Follicular Thyroid Carcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 20 Mar 2028
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Available preoperative fine-needle aspiration cytology (FNAC)
- Postoperative histopathologically confirmed differentiated thyroid carcinoma
Who cannot join
- Poorly differentiated thyroid carcinoma
- Anaplastic thyroid carcinoma
- Medullary thyroid carcinoma
- Non-diagnostic FNAC (Bethesda category I)
- Inadequate follow-up data
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: Relationship Between Preoperative Fine Needle Aspiration Cytology (Bethesda Classification) and Postoperative Risk Stratification in Patients With Differentiated Thyroid Carcinoma
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.
- Conditions
- 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
- Medical subject headings
- Thyroid Cancer, Papillary, Adenocarcinoma, Follicular, Thyroid Nodule
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 month
Secondary outcomes (2)
Proportion of patients with papillary thyroid carcinoma subtype
Proportion of patients with papillary thyroid carcinoma histopathological subtype.
Measured: Baseline
Proportion of patients receiving radioactive iodine therapy
Proportion of patients who received radioactive iodine (RAI) therapy.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion25 Oct 2027 (estimated)
- Study completion20 Mar 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 Differentiated Thyroid CarcinomaStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia Mohamed Kenawy Rezk, Assiut University
- Investigators
- Taha M Zaky, prof, Study chair, Nuclear Medicine Unit, Department of Clinical Oncology and Nuclear Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858097
- Sponsor's protocol ID
- Bethesda-ATA-DTC-2026
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 27418023Bongiovanni 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 22846422Ali 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Preoperative Fine Needle Aspiration Cytology (Bethesda Classification) and Postoperative Risk Stratification in Patients With Differentiated Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT07858097
- Acronym / sponsor ID
- Bethesda-ATA-DTC-2026
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 25 Oct 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 5 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Available preoperative fine-needle aspiration cytology (FNAC)
- Postoperative histopathologically confirmed differentiated thyroid carcinoma
Key exclusion criteria (5 listed)
- Poorly differentiated thyroid carcinoma
- Anaplastic thyroid carcinoma
- Medullary thyroid carcinoma
- Non-diagnostic FNAC (Bethesda category I)
- Inadequate follow-up data
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
Proportion of patients with high ATA risk stratification
Time frame: At 1 month
Proportion of patients classified as high risk according to the American Thyroid Association (ATA) risk stratification system.
2 secondary outcomes
Proportion of patients with papillary thyroid carcinoma subtype
Time frame: Baseline
Proportion of patients receiving radioactive iodine therapy
Time frame: At 6 months
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 5 Oct 2026.
- Background: PubMed 27418023Kitahara 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.
- Background: PubMed 22846422Bongiovanni 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.
- Background: PubMed 37427847Ali 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.
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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.
Taha M Zaky, prof study chair
Nuclear Medicine Unit, Department of Clinical Oncology and Nuclear Medicine, Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Carcinoma and Papillary Thyroid Carcinoma, 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 5 Oct 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 Alia M Kenawy, resident (0 10 97551147 ext. 022, Aliaaliayyy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with high ATA risk stratification (time frame: At 1 month). 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 NCT07858097, 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 5 Oct 2026.