Predictors of Recurrence for High Risk Endometrial Cancer... | NCT04412902

Studies
Predictors of Recurrence for High Risk Endometrial Cancer Patients

NCT04412902

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Dec 9, 2020Actual

Enrollment

92Actual

Phase

Not provided

Conditions

High-risk Endometrial Cancer

Interventions

adjuvant therapy

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 2020

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

Apr 25, 2020Actual

Primary Completion Date

Oct 25, 2020Actual

Completion Date

Nov 25, 2020Actual

First Submitted Date

May 31, 2020

First Submission Date that Met QC Criteria

May 31, 2020

First Posted Date

Jun 2, 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

Dec 7, 2020

Last Update Posted Date

Dec 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief of Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

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

This study will analyze whether there is any difference in recurrence and survival rates among the patients who received different adjuvant therapies.

Detailed Description

The incidence of endometrial cancer is gradually increasing nowaday. The postoperative treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of high-risk endometrial cancer is high.The investigators retrospective study will analyze the factors associated with recurrence of endometrial cancer, especially for different adjuvant therapies.

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

92Actual

Name	Type	Description	Arm Group Labels	Other Names
adjuvant therapy	Drug	Adjuvant chemotherapy and/or radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Factors affecting overall survival	Factors affecting overall survival	10 years

Secondary Outcomes

Measure	Description	Time Frame
Factors affecting progression-free survival	Factors affecting progression-free survival	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with high risk stage I endometrial cancer and all patients with stage II and stage III endometrial cancer and who underwent therapy in Far Eastern Memorial Hospital from 2009/01/01~2019/09/17.

Exclusion Criteria:

Patients with stage I endometrial cancer do not have high risk factors.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

high risk endometrial cancer patients

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All high risk endometrial cancer patients

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

Intervention Browse Module

MeSH Terms

ID	Term
D017024	Chemotherapy, Adjuvant

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided