Sentinel Lymph Nodes Biopsy in Cervical Cancer | NCT06169787

Studies
Sentinel Lymph Nodes Biopsy in Cervical Cancer

NCT06169787

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Jun 17, 2024Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Sentinel Lymph Node

Interventions

sentinel lymph node biopsy
comprehensive pelvic lymphadenectomy

Countries

Taiwan

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2023Actual

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Oct 14, 2023

First Submission Date that Met QC Criteria

Dec 5, 2023

First Posted Date

Dec 14, 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

Jun 13, 2024

Last Update Posted Date

Jun 17, 2024Actual

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

This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.

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

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sentinel Lymph Node		Sentinel lymph node biopsy in patients with early stage cervical cancer	Procedure: sentinel lymph node biopsy
Lymphadenectomy		Comprehensive lymphadenectomy in patients with early stage cervical cancer	Procedure: comprehensive pelvic lymphadenectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sentinel lymph node biopsy	Procedure	sentinel lymph node biopsy	Sentinel Lymph Node

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival	progression free survival between these two groups	5 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival	overall survival between these two groups	5 years
Number of dissected lymph node	Number of dissected lymph node between these two groups

Other Outcomes

Measure	Description	Time Frame
Complications	Compication rates between the traditional and sentinel lymph node dissection groups	5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer

Exclusion Criteria:

Women did not receive surgical treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women with early stage cervical cancer

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women aged 20 and above with early stage cervical cancer, who received surgical treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D021701	Sentinel Lymph Node Biopsy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided