NCT04759053

Brief Summary

The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 9, 2021

Last Update Submit

February 16, 2021

Conditions

Thyroid NoduleThyroid DiseasesThyroid Gland; Node

Keywords

Thyroid noduleCore needle biopsyFNB

Outcome Measures

Primary Outcomes (1)

  • Number of samples in FNB and CNB matching the final pathology

    Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology

    7 days

Study Arms (2)

FNB

ACTIVE COMPARATOR
Procedure: FNBProcedure: Core biopsy

Core biopsy

ACTIVE COMPARATOR
Procedure: FNBProcedure: Core biopsy

Interventions

FNBPROCEDURE

Fine needle aspiration from the nodules

Core biopsyFNB
Core biopsyPROCEDURE

Core biopsy from thyroid nodules

Core biopsyFNB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.

You may not qualify if:

  • Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thyroid NoduleThyroid Diseases

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Assistant lecturer of general surgery

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 17, 2021

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

February 17, 2021

Record last verified: 2021-02