The Role of Central Neck Dissection in Stage N0 Papillary... | NCT04076514

Studies
The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma

NCT04076514

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 14, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Papillary Thyroid Cancer

Interventions

central neck dissection

Countries

Egypt

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 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Nov 1, 2020Estimated

First Submitted Date

Aug 28, 2019

First Submission Date that Met QC Criteria

Aug 30, 2019

First Posted Date

Sep 3, 2019Actual

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 10, 2020

Last Update Posted Date

Jul 14, 2020Actual

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 benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.

Detailed Description

Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with node negative papillary thyroid carcinoma			Procedure: central neck dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
central neck dissection	Procedure	dissection of central cervical lymph node grope in low grade papillary thyroid cancer	patients with node negative papillary thyroid carcinoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection	numbers of positive histopathological lymph node biopsies postoperative	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with papillary thyroid cancer with clinically node negative.

Exclusion Criteria:

patients with clinical evidence of nodal metastases.
patients with a previous history of thyroidectomy.
patients with mixed-type papillary thyroid cancer.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with papillary thyroid carcinoma with clinically negative lymph node who undergo total thyroidectomy and central neck dissetion in assiut university hospital, department of general surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed kamel ali	Contact	00201021259455		ahmed01155@med.aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Kamel	Recruiting	Asyut	Asyut Governorate		Egypt

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
D000077273	Thyroid Cancer, Papillary

Ancestor Terms

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

Browse Leaves

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Browse Branches

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