NCT05521594

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

August 20, 2022

Last Update Submit

September 23, 2022

Conditions

Fine Needle Aspiration CytologyThyroid Diseases

Keywords

FNACthyroid nodulesthyroidectomy

Outcome Measures

Primary Outcomes (4)

  • Incidence of true positive results of FNAC after thyroidectomy

    Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience

    10 days

  • Percentage of malignant thyroid nodules not observed by FNAC

    type of thyroid malignancy not observed by FNAC

    10 days

  • Incidence of false negative results by FNAC

    false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion

    10 days

  • Percentage of Total number of true results of FNAC to the total number of cases

    accuracy of FNAC

    10 days

Study Arms (2)

FNAC

EXPERIMENTAL
Procedure: Fine Needle Aspiration Cytology

post operative hitopathology

EXPERIMENTAL
Procedure: Fine Needle Aspiration Cytology

Interventions

Fine Needle Aspiration CytologyPROCEDURE

Comparison between FNAC and post operative specimen after thyroid surgery

Also known as: Thyrodectomy
FNACpost operative hitopathology

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with no diagnostic FNAC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena Oncology Center

Qina, +2, Egypt

Location

MeSH Terms

Conditions

Thyroid DiseasesThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine System DiseasesThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Officials

  • Amr M Makky, specialist surgical onclogy

    Qena Oncology Center- Medical Military Academy

    STUDY DIRECTOR

  • Abdullah Atyah Ali, Ass.Lecture General Surgery

    Qena Oncology Center--Luxor University

    STUDY DIRECTOR

  • Mohamed Ahmed Orabi, specialist surgical onclogy

    Qena Oncology Center

    PRINCIPAL INVESTIGATOR

  • Mina Romany Tawfeek

    Qena Oncology Center

    STUDY CHAIR

  • Mahmoud Ahmed Dosoky, specialist pathology

    Qena Oncology Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist of surgical oncology at Qena Oncology Center

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 30, 2022

Study Start

January 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations

EG(1)