Hürthle Cell Carcinoma and Follicular Thyroid Carcinoma | NCT05968196

Studies
Hürthle Cell Carcinoma and Follicular Thyroid Carcinoma

NCT05968196

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Aug 1, 2023Actual

Enrollment

221Actual

Phase

Not provided

Conditions

Huerthle Cell Carcinoma

Interventions

Not provided

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

Jul 2023

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, 2000Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Jul 12, 2023

First Submission Date that Met QC Criteria

Jul 20, 2023

First Posted Date

Aug 1, 2023Actual

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

Jul 20, 2023

Last Update Posted Date

Aug 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwangsoon Kim, Assistant Professor, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 goal of this retrospective study is to evaluate in patients with HCC and FTC who underwent lobectomy. The main questions it aims to answer are:

The necessity of completion thyroidectomy based on the clinicopathological characteristics
Prognosis Participants underwent thyroid lobectomy Researchers compared HCC and FTC groups to see the prognosis after lobectomy.

Detailed Description

Background The prognosis of Hürthle cell carcinoma (HCC) and follicular thyroid carcinoma (FTC) is poorly understood. These types of cancers are usually confirmed after diagnostic lobectomy. We aimed to evaluate the clinicopathological characteristics and prognoses of patients with HCC and FTC who did not undergo completion thyroidectomy.

Materials and Methods We screened 221 patients diagnosed with FTC or HCC after thyroid lobectomy at Yonsei Severance Hospital between January 2000 and December 2020. After excluding patients who underwent complete thyroidectomy, 184 patients with FTC and 37 patients with HCC were included.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FTC		Follicular thyroid carcinoma
HCC		Hurthle cell carcinoma

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free survival (DFS)	a comparison of disease-free survival (DFS) between FTC and HCC groups	From January 2000 to March 2023

Secondary Outcomes

Measure	Description	Time Frame
TNM stage	a comparison of TNM stage between FTC and HCC groups	From January 2000 to March 2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Follicular thyroid carcinoma
Hurthle cell carcinoma
Lobectomy

Exclusion Criteria:

Completion thyroidectomy
Total thyroidectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients in FTC and HCC who underwent thyroid lobectomy

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000230	Adenocarcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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