Role of Frozen Section in Categorization of Thyroid Follicular NeoplasmNCT06947629
Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm
A study testing Intraoperative Frozen Section in people with Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of this prospective study is to assess the effectiveness of frozen section in distinguishing between benign and malignant tumors in the category of follicular thyroid neoplasm to prevent over-surgery for benign follicular neoplasm (lobectomy Vs total thyroidectomy). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm
- What is being tested?
- Intraoperative Frozen Section
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2025to 2 May 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases presented with a thyroid nodule, diagnosed as "follicular neoplasm" (Bethesda category IV) by fine needle aspiration cytology, and underwent hemi-thyroidectomy.
Who cannot join
- Cases with thyroid nodule and diagnosed by fine needle aspiration cytology as non-neoplastic lesions, suspicious for malignancy or as malignant.
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
The goal of this prospective study is to assess the effectiveness of frozen section in distinguishing between benign and malignant tumors in the category of follicular thyroid neoplasm to prevent over-surgery for benign follicular neoplasm (lobectomy Vs total thyroidectomy).
The main questions, it aims to answer are:
The follicular neoplasm is benign or malignent? how far is FNAC valid and accurate? Researchers will compare the results of frozen section and paraffin embedded sections to evaluate the validity and accuracy of FNAC.
Read the detailed description
Thyroid tumors are the most common endocrine neoplasms, with their incidence steadily rising over the past few decades, reaching approximately 8.7 cases per 100,000 people annually in Europe. The majority of thyroid tumors are benign accounting for over 90% of cases, whereas malignant thyroid tumors are relatively less common. Thyroid cancer represents 1-2% of all newly diagnosed malignancies worldwide, with papillary thyroid carcinoma (PTC) being the most prevalent (80%) followed by follicular thyroid carcinomas (FTC) (15%). Fine needle aspiration cytology (FNAC) is the primarily diagnostic tool for thyroid nodule. However, its accuracy in distinguishing between benign and malignant follicular neoplasms is limited, necessitating further histopathological evaluation. The Bethesda system classifies FNAC results into six categories, with follicular neoplasm/suspicious for follicular neoplasm (category IV) carrying a moderate risk of malignancy. Differentiating between benign and malignant follicular neoplasms requires assessing capsular and vascular invasion. Intraoperative frozen section (FS) has been used for decades to provide rapid histologic assessment guiding the extent of surgery (lobectomy Vs total thyroidectomy). However, its utility remains controversial due to variability in diagnostic accuracy and cost-effectiveness. The recent 5th edition of the WHO classification (2023) categorizes follicular-derived thyroid tumors into benign, low-risk and malignant neoplasms, further refining diagnostic criteria. This study aims to evaluate the accuracy of FNAC and FS in diagnosing follicular thyroid neoplasms, optimizing surgical decisions and reducing unnecessary total thyroidectomies in benign cases.
- Being tested
- Intraoperative Frozen Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Frozen SectionDiagnostic test
Intraoperative Frozen Section analysis which will include the following steps:
- The specimen will undergo both gross and microscopic examination:
- Gross examination: Evaluation of nodular features including, multiplicity, size, outlines, color and consistency.
- Microscopic examination: Assessment of capsular pattern, capsular invasion, thickness of capsule, vascular invasion and number of invaded vessels and the presence or absence of papillary structures.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Evaluation Group | Experimental | Not described Receives: Diagnostic Test: Intraoperative Frozen Section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign in Thyroid Follicular Neoplasm
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign.
Measured: two weeks
Secondary outcomes (1)
Assessment of the accuracy of fine needle aspiration cytology in diagnosis of follicular neoplasm.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start2 May 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Frozen Section in Categorization of Thyroid Follicular NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamdy Sayed, New Valley University
- Investigators
- Howayda I Hassan, professor, Study chair, Faculty of Medicine, Assiut Universiy, Assiut, EgyptMahmoud F Sherif, Assistant Professor, Study director, Faculty of Medicine, Assiut Universiy, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947629
- Sponsor's protocol ID
- 04-2025-201196
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with the corresponding offer on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm
- ClinicalTrials.gov ID
- NCT06947629
- Acronym / sponsor ID
- 04-2025-201196
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 May 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 27 Apr 2025 (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 goal of this prospective study is to assess the effectiveness of frozen section in distinguishing between benign and malignant tumors in the category of follicular thyroid neoplasm to prevent over-surgery for benign follicular neoplasm (lobectomy Vs total thyroidectomy).
The main questions, it aims to answer are:
The follicular neoplasm is benign or malignent? how far is FNAC valid and accurate? Researchers will compare the results of frozen section and paraffin embedded sections to evaluate the validity and accuracy of FNAC.
Detailed description
Thyroid tumors are the most common endocrine neoplasms, with their incidence steadily rising over the past few decades, reaching approximately 8.7 cases per 100,000 people annually in Europe. The majority of thyroid tumors are benign accounting for over 90% of cases, whereas malignant thyroid tumors are relatively less common. Thyroid cancer represents 1-2% of all newly diagnosed malignancies worldwide, with papillary thyroid carcinoma (PTC) being the most prevalent (80%) followed by follicular thyroid carcinomas (FTC) (15%). Fine needle aspiration cytology (FNAC) is the primarily diagnostic tool for thyroid nodule. However, its accuracy in distinguishing between benign and malignant follicular neoplasms is limited, necessitating further histopathological evaluation. The Bethesda system classifies FNAC results into six categories, with follicular neoplasm/suspicious for follicular neoplasm (category IV) carrying a moderate risk of malignancy. Differentiating between benign and malignant follicular neoplasms requires assessing capsular and vascular invasion. Intraoperative frozen section (FS) has been used for decades to provide rapid histologic assessment guiding the extent of surgery (lobectomy Vs total thyroidectomy). However, its utility remains controversial due to variability in diagnostic accuracy and cost-effectiveness. The recent 5th edition of the WHO classification (2023) categorizes follicular-derived thyroid tumors into benign, low-risk and malignant neoplasms, further refining diagnostic criteria. This study aims to evaluate the accuracy of FNAC and FS in diagnosing follicular thyroid neoplasms, optimizing surgical decisions and reducing unnecessary total thyroidectomies in benign cases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Evaluation Group | Experimental | Diagnostic Test: Intraoperative Frozen Section |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases presented with a thyroid nodule, diagnosed as "follicular neoplasm" (Bethesda category IV) by fine needle aspiration cytology, and underwent hemi-thyroidectomy.
Key exclusion criteria (1 listed)
- Cases with thyroid nodule and diagnosed by fine needle aspiration cytology as non-neoplastic lesions, suspicious for malignancy or as malignant.
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 |
|---|---|---|
| Intraoperative Frozen SectionIntraoperative Frozen Section analysis which will include the following steps: - The specimen will undergo both gross and microscopic examination: 1. Gross examination: Evaluation of nodular features including, multiplicity, size, outlines, color and consistency. 2. Microscopic examination: Assessment of capsular pattern, capsular invasion, thickness of capsule, vascular invasion and number of invaded vessels and the presence or absence of papillary structures. | Diagnostic test | Diagnostic Evaluation Group |
Primary outcome
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign in Thyroid Follicular Neoplasm
Time frame: two weeks
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign.
1 secondary outcome
Assessment of the accuracy of fine needle aspiration cytology in diagnosis of follicular neoplasm.
Time frame: three weeks
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 27 Apr 2025.
- Individual participant dataSharing planned: No. Data is available with the corresponding offer on reasonable request
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.
Howayda I Hassan, professor study chair
Faculty of Medicine, Assiut Universiy, Assiut, Egypt
Mahmoud F Sherif, Assistant Professor study director
Faculty of Medicine, Assiut Universiy, Assiut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Frozen Section in people with Role of Frozen Section in Categorization of Thyroid Follicular Neoplasm, run by Assiut 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: opening soon, as of the sponsor's last update on 27 Apr 2025. 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 Mohamed H Sayed, MBBCh (+201004419027, MohamedHamdy2020@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of frozen section evaluation in the diagnosis of malignant follicular neoplasm from benign in Thyroid Follicular Neoplasm (time frame: two weeks). 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 27 Apr 2025.