NCT06782828

Brief Summary

Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 25, 2023

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 20, 2025

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 25, 2023

Last Update Submit

January 17, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Incidence of true positive results of FNAC after thyroidectomy

    Accuracy of FNAC in thyroid nodules compared to surgical specimen histopathological examination

    12 days

  • Percentage of malignant thyroid nodules not observed by FNAC

    Percentage of malignant thyroid nodules that FNAC fails to detect

    12 days

  • Incidence of false negative results by FNAC

    False negative that diagnosed by FNAC not malignant but proved malignancy after surgical excision

    12 days

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

    Accuracy of FNAC

    12 days

Interventions

observe results of FNAC and compare it with results of histopathological examination to detect accuracy of FNAC in diagnosis of thyroid nodules.

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presented to General Surgery Department with either solitary or multiple suspicious thyroid nodules during time of research.

You may qualify if:

  • thyroid disease
  • multinodular
  • single nodule
  • TIRAD 3 or more by US
  • thyroid disease underwent FNAC then surgery
  • all age groups
  • patient fit for surgery

You may not qualify if:

  • patients with comorbidities.
  • patients unfit for surgery
  • patients who refused surgery.
  • Patient with no diagnostic FNAC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Poller DN, Stelow EB, Yiangou C. Thyroid FNAC cytology: can we do it better? Cytopathology. 2008 Feb;19(1):4-10. doi: 10.1111/j.1365-2303.2007.00492.x. Epub 2007 Oct 3.

    PMID: 17916090BACKGROUND
  • Bhise SV, Shaikh A, Hippargekar PM, Kothule S. A Prospective Study of Ultrasonographic and FNAC Correlation of Thyroid Swellings with Histopathology. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):1942-1948. doi: 10.1007/s12070-020-01922-w. Epub 2020 Jun 24.

    PMID: 36452634BACKGROUND
  • Momin MA, Bhuiyan FU, Chakraborty S, Kar NK. FNAC and Its Utility in Solitary Thyroid Nodule and Its Correlation with Histopathological Examination. Mymensingh Med J. 2019 Apr;28(2):356-363.

    PMID: 31086151BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Mostafa Abed Abdulmoneim Mohammed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 20, 2025

Study Start

March 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 20, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share