UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063469 |
|---|---|
| Receipt number | R000072637 |
| Scientific Title | A Multicenter Survey on Ovarian Preservation and Hormone Replacement Therapy in Women Under 45 with Stage IA Endometrioid Endometrial Cancer (G1/G2) |
| Date of disclosure of the study information | 2026/10/30 |
| Last modified on | 2026/10/30 07:54:09 |
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Basic information
Public title
A Multicenter Survey on Ovarian Preservation and Hormone Replacement Therapy in Women Under 45 with Stage IA Endometrioid Endometrial Cancer (G1/G2)
Acronym
JGOG2056S
Scientific Title
A Multicenter Survey on Ovarian Preservation and Hormone Replacement Therapy in Women Under 45 with Stage IA Endometrioid Endometrial Cancer (G1/G2)
Scientific Title:Acronym
JGOG2056S
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current practice of ovarian preservation and hormone replacement therapy (HRT) in Japan among women younger than 45 years diagnosed with stage IA endometrial cancer (grade 1 or 2 endometrioid carcinoma).
Basic objectives2
Others
Basic objectives -Others
Comparison of ovarian preservation and HRT use rates between 2014-2016 and 2023-2025
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Annual rates of ovarian preservation and hormone replacement therapy (HRT) use
(2) Comparison of the rates of ovarian preservation and HRT use between 2014-2016 and 2023-2025
Key secondary outcomes
(1) Association between body mass index (BMI) and hormone replacement therapy (HRT) use
(2) Association between smoking status and HRT use
(3) Association between ovarian preservation and contraindications or conditions requiring caution for HRT
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Patients younger than 45 years of age at the time of surgery.
(2) Patients diagnosed with stage IA endometrial cancer (grade 1 or 2 endometrioid carcinoma) based on postoperative pathological examination, according to the JSOG 2011 and FIGO 2008 staging systems.
(3) Patients who underwent surgery without oophorectomy due to a preoperative diagnosis of atypical endometrial hyperplasia and were subsequently diagnosed with endometrial cancer are also eligible.
(4) Patients are eligible regardless of whether lymphadenectomy was performed.
(5) Patients without suspected lymph node metastasis before surgery.
(6) Patients who underwent surgery between January 1, 2014 and December 31, 2016, or between January 1, 2023 and December 31, 2025.
(7) Patients who were premenopausal at the time of surgery.
Key exclusion criteria
Patients deemed ineligible for study enrollment by the principal investigator.
Target sample size
2700
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Matsumura |
Organization
Hirosaki University Hospital
Division name
Obstetrics and Gynecology
Zip code
036-8562
Address
5 Zaifucho, Hirosaki, Aomori
TEL
0172-39-5107
y-matsu@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Matsumura |
Organization
Hirosaki University Hospital
Division name
Obstetrics and Gynecology
Zip code
036-8562
Address
5 Zaifucho, Hirosaki, Aomori
TEL
0172-39-5107
Homepage URL
https://jgog.gr.jp/
y-matsu@hirosaki-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Gynecologic Oncology Group
Address
4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, JAPAN
Tel
03-5206-1982
info@jgog.gr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eligible Institutions: JGOG participating institutions
Management information
Registered date
| 2026 | Year | 10 | Month | 30 | Day |
Last modified on
| 2026 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072637
