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

Primary Purpose

Fine Needle Aspiration Cytology, Thyroid Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fine Needle Aspiration Cytology
Sponsored by
Qena Oncology Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fine Needle Aspiration Cytology focused on measuring FNAC, thyroid nodules, thyroidectomy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with no diagnostic FNAC

Sites / Locations

  • Qena Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FNAC

post operative hitopathology

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2022
Last Updated
September 23, 2022
Sponsor
Qena Oncology Center
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1. Study Identification

Unique Protocol Identification Number
NCT05521594
Brief Title
Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
Acronym
Thyroid FNAC
Official Title
Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qena Oncology Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fine Needle Aspiration Cytology, Thyroid Diseases
Keywords
FNAC, thyroid nodules, thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FNAC
Arm Type
Experimental
Arm Title
post operative hitopathology
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Fine Needle Aspiration Cytology
Other Intervention Name(s)
Thyrodectomy
Intervention Description
Comparison between FNAC and post operative specimen after thyroid surgery
Primary Outcome Measure Information:
Title
Incidence of true positive results of FNAC after thyroidectomy
Description
Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience
Time Frame
10 days
Title
Percentage of malignant thyroid nodules not observed by FNAC
Description
type of thyroid malignancy not observed by FNAC
Time Frame
10 days
Title
Incidence of false negative results by FNAC
Description
false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion
Time Frame
10 days
Title
Percentage of Total number of true results of FNAC to the total number of cases
Description
accuracy of FNAC
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Makky, specialist surgical onclogy
Organizational Affiliation
Qena Oncology Center- Medical Military Academy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdullah Atyah Ali, Ass.Lecture General Surgery
Organizational Affiliation
Qena Oncology Center--Luxor University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmed Orabi, specialist surgical onclogy
Organizational Affiliation
Qena Oncology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mina Romany Tawfeek
Organizational Affiliation
Qena Oncology Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmoud Ahmed Dosoky, specialist pathology
Organizational Affiliation
Qena Oncology Center
Official's Role
Study Director
Facility Information:
Facility Name
Qena Oncology Center
City
Qinā
ZIP/Postal Code
+2
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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