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

Thyroid Diseases Clinical Trial

— Thyroid FNAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521594
• Other study ID #: Qena Oncology Center 2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: Qena Oncology Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 its use has markedly decreased the number of unnecessary thyroid surgeries(2).

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Thyroid diseases

• Multi nodullar

• single nodules

• diffuse goiter

• Thyroid diseases underwent FNAC Then Thyroid surgery

Exclusion Criteria:

• Patients with no diagnostic FNAC

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• Fine Needle Aspiration Cytology
Comparison between FNAC and post operative specimen after thyroid surgery

Locations

Country	Name	City	State
Egypt	Qena Oncology Center	Qina

Sponsors (1)

Lead Sponsor	Collaborator
Qena Oncology Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of true positive results of FNAC after thyroidectomy	Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience	10 days
Primary	Percentage of malignant thyroid nodules not observed by FNAC	type of thyroid malignancy not observed by FNAC	10 days
Primary	Incidence of false negative results by FNAC	false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion	10 days
Primary	Percentage of Total number of true results of FNAC to the total number of cases	accuracy of FNAC	10 days