Fine Needle Aspiration CytologyThyroid FNACNCT05521594
Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
A study testing Fine Needle Aspiration Cytology in people with Fine Needle Aspiration Cytology and Thyroid Diseases, run by Qena Oncology Center at 1 site in Egypt.
Trial summary
Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Fine Needle Aspiration Cytology, Thyroid Diseases
- What is being tested?
- Fine Needle Aspiration Cytology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 31 Jul 2022
- Phase
- Interventional
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thyroid diseases
- Multi nodullar
- single nodules
- diffuse goiter
- Thyroid diseases underwent FNAC Then Thyroid surgery
Who cannot join
- Patients with no diagnostic FNAC
Trial locations and contacts
1 site in 1 country.
About this study
Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).
Read the detailed description
it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.[2,3] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.[4] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid [5].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules [2,3]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm [2]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious [3].
- Conditions
- Fine Needle Aspiration Cytology, Thyroid Diseases
- Being tested
- Fine Needle Aspiration Cytology
- Keywords
- FNAC, thyroid nodules, thyroidectomy
- Medical subject headings
- Thyroid Diseases, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Needle Aspiration CytologyProcedure or surgery
Also called Thyrodectomy
Comparison between FNAC and post operative specimen after thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| FNAC | Experimental | Not described Receives: Procedure: Fine Needle Aspiration Cytology |
| post operative hitopathology | Experimental | Not described Receives: Procedure: Fine Needle Aspiration Cytology |
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 to surgical specimen : QOC experience
Measured: 10 days
Percentage of malignant thyroid nodules not observed by FNAC
type of thyroid malignancy not observed by FNAC
Measured: 10 days
Incidence of false negative results by FNAC
false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion
Measured: 10 days
Percentage of Total number of true results of FNAC to the total number of cases
accuracy of FNAC
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fine Needle Aspiration CytologyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qena Oncology Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Ahmed Orabi, Qena Oncology Center
- Investigators
- Amr M Makky, specialist surgical onclogy, Study director, Qena Oncology Center- Medical Military AcademyAbdullah Atyah Ali, Ass.Lecture General Surgery, Study director, Qena Oncology Center--Luxor UniversityMohamed Ahmed Orabi, specialist surgical onclogy, Principal investigator, Qena Oncology CenterMina Romany Tawfeek, Study chair, Qena Oncology CenterMahmoud Ahmed Dosoky, specialist pathology, Study director, Qena Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521594
- Sponsor's protocol ID
- Qena Oncology Center 2
- Acronym
- Thyroid FNAC
- Status last verified
- Sep 2022
- First submitted
- 20 Aug 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
- ClinicalTrials.gov ID
- NCT05521594
- Acronym / sponsor ID
- Thyroid FNAC / Qena Oncology Center 2
- Conditions
- Fine Needle Aspiration Cytology, Thyroid Diseases
- Keywords
- FNAC, thyroid nodules, thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Qena Oncology CenterOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 30 Aug 2022 (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.
Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).
Detailed description
it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.[2,3] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.[4] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid [5].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules [2,3]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm [2]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious [3].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNAC | Experimental | Procedure: Fine Needle Aspiration Cytology |
| post operative hitopathology | Experimental | Procedure: Fine Needle Aspiration Cytology |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Thyroid diseases
- Multi nodullar
- single nodules
- diffuse goiter
- Thyroid diseases underwent FNAC Then Thyroid surgery
Key exclusion criteria (1 listed)
- Patients 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 |
|---|---|---|
| Fine Needle Aspiration CytologyAlso: ThyrodectomyComparison between FNAC and post operative specimen after thyroid surgery | Procedure or surgery | FNAC, post operative hitopathology |
Primary outcome
Incidence of true positive results of FNAC after thyroidectomy
Time frame: 10 days
Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience
Percentage of malignant thyroid nodules not observed by FNAC
Time frame: 10 days
type of thyroid malignancy not observed by FNAC
Incidence of false negative results by FNAC
Time frame: 10 days
false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion
Percentage of Total number of true results of FNAC to the total number of cases
Time frame: 10 days
accuracy of FNAC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Amr M Makky, specialist surgical onclogy study director
Qena Oncology Center- Medical Military Academy
Abdullah Atyah Ali, Ass.Lecture General Surgery study director
Qena Oncology Center--Luxor University
Mohamed Ahmed Orabi, specialist surgical onclogy principal investigator
Qena Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine Needle Aspiration Cytology in people with Fine Needle Aspiration Cytology and Thyroid Diseases, run by Qena Oncology Center 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 5 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: finished, as of the sponsor's last update on 26 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 10 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?
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 26 Sep 2022.