The Safety of Ovarian Preservation in Stage IA Endometria... | NCT01820884

Studies
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

NCT01820884

Sponsor

Ding Ma

Status

Active, not recruiting

Last Update Posted

Apr 2, 2024Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Endometrial Neoplasms

Interventions

TH
TH/BSO
BPLND

Countries

China

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

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 21, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 29, 2013Estimated

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

Apr 1, 2024

Last Update Posted Date

Apr 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and TechnologySponsor-Investigator

Lead Sponsor

Ding MaOTHER

Collaborators

Name	Class
Shandong University	OTHER
Huazhong University of Science and Technology	OTHER
Zhejiang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total Hysterectomy (TH)	Experimental	Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND).	Procedure: TH Procedure: BPLND
TH and bilateral salpingo-oophorectomy (TH/BSO)	Active Comparator	Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection.	Procedure: TH/BSO Procedure: BPLND

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TH	Procedure	Total hysterectomy	Total Hysterectomy (TH)
TH/BSO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free survival (DFS)		3-year DFS

Secondary Outcomes

Measure	Description	Time Frame
Clinical gynecologic endocrine function	To observe the level of female hormone，i.e., estrogen, FSH, LH	1-year period
Quality of Life		3-year period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

FIGO stage: ⅠA, endometrial carcinoma;
Female, Chinese women;
premenopausal women；
≤ 50 years old;
Pathological diagnosis by curettage/hysteroscopy : G1
No prior treatment;
Provide written informed consent.

Exclusion Criteria:

The suspicious metastasis of ovarian;
Family history of ovarian cancer;
Suffering from other malignancies;
Concurrently participating in other clinical trials;
Unable or unwilling to sign informed consents;
Unable or unwilling to abide by protocol.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beihua Kong, MD, PhD	Shandong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

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