Effectiveness of Core-Needle US Guided Biopsy as Primary... | NCT04759053

Studies
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules

NCT04759053

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Feb 17, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Thyroid Nodule
Thyroid Diseases
Thyroid Gland; Node

Interventions

FNB
Core biopsy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Feb 9, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2021

Last Update Posted Date

Feb 17, 2021Actual

Name	Class
Alexandria University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FNB	Active Comparator		Procedure: FNB Procedure: Core biopsy
Core biopsy	Active Comparator		Procedure: FNB Procedure: Core biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FNB	Procedure	Fine needle aspiration from the nodules	Core biopsy FNB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001707	Biopsy, Needle

Ancestor Terms

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided