Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience

Not Applicable

Completed

• Conditions: Fine Needle Aspiration Cytology; Thyroid Diseases
• Interventions: Procedure: Fine Needle Aspiration Cytology

• Registration Number: NCT05521594
• Lead Sponsor: Qena Oncology Center

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 \[3\].

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Study First Submitted: 2022-08-20
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

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

Exclusion Criteria

• Patients with no diagnostic FNAC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
post operative hitopathology	Fine Needle Aspiration Cytology	-
FNAC	Fine Needle Aspiration Cytology	-

Primary Outcome Measures

Name	Time	Method
Incidence of false negative results by FNAC	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	10 days	accuracy of FNAC
Incidence of true positive results of FNAC after thyroidectomy	10 days	Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience
Percentage of malignant thyroid nodules not observed by FNAC	10 days	type of thyroid malignancy not observed by FNAC

Trial Locations

Locations (1)

Qena Oncology Center; 🇪🇬 Qinā, Egypt