Thyroid NoduleNCT06782828
Accuracy of FNAC in Diagnosis of Thyroid Nodules
An observational study of Thyroid Nodule, run by Assiut University.
Trial summary
Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- observe results of FNAC
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2025
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presented to General Surgery Department with either solitary or multiple suspicious thyroid nodules during time of research.
Who may be able to join
- thyroid disease
- multinodular
- single nodule
- TIRAD 3 or more by US
- thyroid disease underwent FNAC then surgery
- all age groups
- patient fit for surgery
Who cannot join
- patients with comorbidities.
- patients unfit for surgery
- patients who refused surgery.
- Patient with no diagnostic FNAC.
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
Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules
Read the detailed description
Accuracy in diagnosis in any case is required, and this is beneficial to the patient and the physician, and with the development that currently exists and the trend to use less invasive techniques, accuracy of FNAC should be studied well.1.Thyroid nodules are common and the principal method of diagnosis is fine-needle aspiration cytology (FNAC).2. Can investigators depend on FNAC alone in diagnosis of thyroid nodule in the future?!3. In this study, investigators will compare the results of (FNAC) versus (Biopsy) in diagnosis of thyroid nodule in AUH , to detect the degree of accuracy of FNAC.4. FNAC is a simple, safe, cost-effective and accurate diagnostic tool for the initial screening of patients with thyroid nodules.5. Background Routine application of fine needle aspiration cytology (FNAC) has decreased unnecessary referral of thyroid nodules for surgical treatment and has also increased the cancer rates found in surgery materials. Success of thyroid FNAC depends on skilled aspiration, skilled cytological interpretation and rational analysis of cytological and clinical data. The aim of this study was to determine the diagnostic accuracy rates of thyroid FNAC results obtained in our hospital.6. The FNAC is a sensitive, specific, and accurate initial diagnostic test for the preoperative evaluation of patients with thyroid swellings in our setting as well. The correlation of cytological and histopathological diagnoses is an important quality assurance method, as it allows cytopathologists to calculate their false-positive and false negative results.7
- Conditions
- Thyroid Nodule
- Being tested
- observe results of FNAC
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observe results of FNACOther
observe results of FNAC and compare it with results of histopathological examination to detect accuracy of FNAC in diagnosis of thyroid nodules.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of true positive results of FNAC after thyroidectomy
Accuracy of FNAC in thyroid nodules compared to surgical specimen histopathological examination
Measured: 12 days
Percentage of malignant thyroid nodules not observed by FNAC
Percentage of malignant thyroid nodules that FNAC fails to detect
Measured: 12 days
Incidence of false negative results by FNAC
False negative that diagnosed by FNAC not malignant but proved malignancy after surgical excision
Measured: 12 days
Percentage of total number of true results of FNAC to the total number of cases
Accuracy of FNAC
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 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 Thyroid NoduleStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abed Abdulmoneim Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782828
- Sponsor's protocol ID
- FNAC in thyroid nodules
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poller DN, Stelow EB, Yiangou C. Thyroid FNAC cytology: can we do it better? Cytopathology. 2008 Feb;19(1):4-10. doi: 10.1111/j.1365-2303.2007.00492.x. Epub 2007 Oct 3.
PubMed 17916090Bhise SV, Shaikh A, Hippargekar PM, Kothule S. A Prospective Study of Ultrasonographic and FNAC Correlation of Thyroid Swellings with Histopathology. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):1942-1948. doi: 10.1007/s12070-020-01922-w. Epub 2020 Jun 24.
PubMed 36452634Momin MA, Bhuiyan FU, Chakraborty S, Kar NK. FNAC and Its Utility in Solitary Thyroid Nodule and Its Correlation with Histopathological Examination. Mymensingh Med J. 2019 Apr;28(2):356-363.
PubMed 31086151
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of FNAC in Diagnosis of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT06782828
- Acronym / sponsor ID
- FNAC in thyroid nodules
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Jan 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.
Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules
Detailed description
Accuracy in diagnosis in any case is required, and this is beneficial to the patient and the physician, and with the development that currently exists and the trend to use less invasive techniques, accuracy of FNAC should be studied well.1.Thyroid nodules are common and the principal method of diagnosis is fine-needle aspiration cytology (FNAC).2. Can investigators depend on FNAC alone in diagnosis of thyroid nodule in the future?!3. In this study, investigators will compare the results of (FNAC) versus (Biopsy) in diagnosis of thyroid nodule in AUH , to detect the degree of accuracy of FNAC.4. FNAC is a simple, safe, cost-effective and accurate diagnostic tool for the initial screening of patients with thyroid nodules.5. Background Routine application of fine needle aspiration cytology (FNAC) has decreased unnecessary referral of thyroid nodules for surgical treatment and has also increased the cancer rates found in surgery materials. Success of thyroid FNAC depends on skilled aspiration, skilled cytological interpretation and rational analysis of cytological and clinical data. The aim of this study was to determine the diagnostic accuracy rates of thyroid FNAC results obtained in our hospital.6. The FNAC is a sensitive, specific, and accurate initial diagnostic test for the preoperative evaluation of patients with thyroid swellings in our setting as well. The correlation of cytological and histopathological diagnoses is an important quality assurance method, as it allows cytopathologists to calculate their false-positive and false negative results.7
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presented to General Surgery Department with either solitary or multiple suspicious thyroid nodules during time of research.
Key inclusion criteria (7 listed)
- thyroid disease
- multinodular
- single nodule
- TIRAD 3 or more by US
- thyroid disease underwent FNAC then surgery
Key exclusion criteria (4 listed)
- patients with comorbidities.
- patients unfit for surgery
- patients who refused surgery.
- Patient with no diagnostic FNAC.
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 |
|---|---|---|
| observe results of FNACobserve results of FNAC and compare it with results of histopathological examination to detect accuracy of FNAC in diagnosis of thyroid nodules. | Other | – |
Primary outcome
Incidence of true positive results of FNAC after thyroidectomy
Time frame: 12 days
Accuracy of FNAC in thyroid nodules compared to surgical specimen histopathological examination
Percentage of malignant thyroid nodules not observed by FNAC
Time frame: 12 days
Percentage of malignant thyroid nodules that FNAC fails to detect
Incidence of false negative results by FNAC
Time frame: 12 days
False negative that diagnosed by FNAC not malignant but proved malignancy after surgical excision
Percentage of total number of true results of FNAC to the total number of cases
Time frame: 12 days
Accuracy of FNAC
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 20 Jan 2025.
- Background: PubMed 17916090Poller DN, Stelow EB, Yiangou C. Thyroid FNAC cytology: can we do it better? Cytopathology. 2008 Feb;19(1):4-10. doi: 10.1111/j.1365-2303.2007.00492.x. Epub 2007 Oct 3.
- Background: PubMed 36452634Bhise SV, Shaikh A, Hippargekar PM, Kothule S. A Prospective Study of Ultrasonographic and FNAC Correlation of Thyroid Swellings with Histopathology. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):1942-1948. doi: 10.1007/s12070-020-01922-w. Epub 2020 Jun 24.
- Background: PubMed 31086151Momin MA, Bhuiyan FU, Chakraborty S, Kar NK. FNAC and Its Utility in Solitary Thyroid Nodule and Its Correlation with Histopathological Examination. Mymensingh Med J. 2019 Apr;28(2):356-363.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, 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 7 inclusion and 4 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 20 Jan 2025. 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 Mostafa Abed Abdulmoneim Mohammed (01142799359, mostafaabed1417@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of true positive results of FNAC after thyroidectomy (time frame: 12 days). The study lists 4 primary outcomes in all. 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 NCT06782828, 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 20 Jan 2025.