Papillary Thyroid Cancer and Central Lymp Node Dissection | NCT05873283

Studies
Papillary Thyroid Cancer and Central Lymp Node Dissection

NCT05873283

Sponsor

Başakşehir Çam & Sakura City Hospital

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Papillary Thyroid Cancer

Interventions

Not provided

Countries

Turkey (Türkiye)

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

May 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

Jun 12, 2020Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Mar 24, 2023Actual

First Submitted Date

May 15, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 24, 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

May 15, 2023

Last Update Posted Date

May 24, 2023Actual

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

Papillary cancer is a disease that spreads through lymphatic ways and its treatment is surgery. We performed prophylactic central dissection in addition to bilateral total thyroidectomy in patients with bethesda 5 and bethesda 6 biopsy results. We evaluated the pathology results retrospectively.

Detailed Description

Not provided

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

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reaching 100 patients was the first target	100 patients	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- B5 and B6 biopsy results

Exclusion Criteria:

- lobectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with B5 and B6 biopsy results who underwent bilateral total thyroidectomy and central lymph node dissection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BasaksehirCamSakuraSehirH		Istanbul			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40153045	Derived	Ozel TM, Soytas Y, Akbulut S, Celik A, Yildiz G, Karatay H, Sari S. The necessity of prophylactic central lymph node dissection in clinically n0 papillary thyroid carcinoma: perspective from the endemic region. Langenbecks Arch Surg. 2025 Mar 28;410(1):109. doi: 10.1007/s00423-025-03667-y.

ID	Term
D000231	Adenocarcinoma, Papillary
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial