Ketohexokinase Isoforms in Endometrial Cancer. | NCT03931265

Studies
Ketohexokinase Isoforms in Endometrial Cancer.

NCT03931265

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Sep 15, 2023Actual

Enrollment

220Estimated

Phase

Not provided

Conditions

Endometrial Cancer

Interventions

ketohexokinase

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

Sep 2023

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

Apr 11, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 25, 2019

First Submission Date that Met QC Criteria

Apr 25, 2019

First Posted Date

Apr 30, 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

Sep 14, 2023

Last Update Posted Date

Sep 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Name	Class
Gynecologic Oncology Group	NETWORK

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

Our preliminary analysis with clinical database suggested that, in patients with type I endometrial cancer, high ketohexokinase-expressing group have lower survival probabilities than low ketohexokinase-expressing group. To understand the importance of ketohexokinase expression and isoform switch during the development of type I endometrial cancer, we propose a series of in vitro experiments and clinical examinations in this project.

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

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ketohexokinase	Diagnostic Test	Check the isoforms of ketohexokinase in the specimen of endometrial cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The role of ketohexokinase isoforms in the overall survival of endometrial cancer.	Cox proportional hazard regression to evaluate the role of ketohexokinase isoforms in the overall survival of endometrial cancer.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Correlation of ketohexokinase isoforms with the other prognostic risk factors	Correlation of ketohexokinase isoforms with deep myometrial invasion, tumor grade, lymph node metastasis, FIGO stage, tumor size, progression-free survival, etc.	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>20 years
Women with endometrial cancer who are about to be admitted to hospital for gynecological staging.
Women who have undergone gynecological staging surgery for endometrial cancer in the past.

Exclusion Criteria:

Women with endometrial cancer who receive preoperative chemotherapy or radiation therapy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with endometrial cancer who underwent staging surgeries in the Far Eastern Memorial Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sheng-Mou Hsiao, MD	Contact	+886289667000	1818	smhsiao2@gmail.com

Overall Officials

Not provided

Locations

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

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