3 Year Recurrence Free Survival in Ultra-low-risk Endomet... | NCT04227249

Studies
3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer

NCT04227249

Sponsor

Seoul National University Hospital

Status

Not yet recruiting

Last Update Posted

Jan 14, 2020Actual

Enrollment

153Estimated

Phase

Not provided

Conditions

Endometrial Cancer

Interventions

no lymph node dissection

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2020Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Jan 2, 2020

First Submission Date that Met QC Criteria

Jan 9, 2020

First Posted Date

Jan 13, 2020Actual

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

Jan 12, 2020

Last Update Posted Date

Jan 14, 2020Actual

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

To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection

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

153Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental		women who do not undergo lymph node dissection	Procedure: no lymph node dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no lymph node dissection	Procedure	do not undergo lymph node dissection	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 year recurrence free survival	3 year recurrence free survival	3 year since surgery

Secondary Outcomes

Measure	Description	Time Frame
5 year recurrence free survival	5 year recurrence free survival	5 year since surgery
5 year overall survival	5 year overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

endometrioid type
anticipated surgery omitting lymph node dissection for endometrial cancer
pelvis MRI, CA125 - satisfying KGOG criteria
no distant metastasis
age 19 or more

Exclusion Criteria:

other cancer within 5 yr
previous hysterectomy
previous therapy for endometrial cancer

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

endometrial cancer with ultra-low risk for lymph node metastasis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
kidong kim, md	Contact	82 31 787 7262		kidong.kim.md@gmail.com

Overall Officials

Not provided

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided