Clinical trial NCT05521594: Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
Official title: Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fine Needle Aspiration Cytology
Thyroid Diseases
Keywords: FNAC
thyroid nodules
thyroidectomy
Lead sponsor: Qena Oncology Center
Sponsor class: OTHER_GOV
First posted: 2022-08-30
Enrollment: 86
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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 \[3\].

Eligibility criteria: Inclusion Criteria:

* Thyroid diseases
* Multi nodullar
* single nodules
* diffuse goiter
* Thyroid diseases underwent FNAC Then Thyroid surgery

Exclusion Criteria:

* Patients with no diagnostic FNAC

Primary outcomes:
measure: Incidence of true positive results of FNAC after thyroidectomy
timeFrame: 10 days
measure: Percentage of malignant thyroid nodules not observed by FNAC
timeFrame: 10 days
measure: Incidence of false negative results by FNAC
timeFrame: 10 days
measure: Percentage of Total number of true results of FNAC to the total number of cases
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Oncology Center
Study officials:
affiliation: Qena Oncology Center- Medical Military Academy
name: Amr M Makky, specialist surgical onclogy
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center--Luxor University
name: Abdullah Atyah Ali, Ass.Lecture General Surgery
role: STUDY_DIRECTOR
affiliation: Qena Oncology Center
name: Mohamed Ahmed Orabi, specialist surgical onclogy
role: PRINCIPAL_INVESTIGATOR
affiliation: Qena Oncology Center
name: Mina Romany Tawfeek
role: STUDY_CHAIR
affiliation: Qena Oncology Center
name: Mahmoud Ahmed Dosoky, specialist pathology
role: STUDY_DIRECTOR
References: