UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034254 |
|---|---|
| Receipt number | R000038795 |
| Scientific Title | Japan Society of Obstetrics and Gynecology Gynecologic Tumor Committee: Survey on Fertility-Sparing Treatment for Early stage Endometrial Cancer in Japan |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2023/04/02 14:24:16 |
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Basic information
Public title
Japan Society of Obstetrics and Gynecology Gynecologic Tumor Committee: Survey on Fertility-Sparing Treatment for Early stage Endometrial Cancer in Japan
Acronym
Survey on Fertility-Sparing Treatment for Endometrial Cancer
Scientific Title
Japan Society of Obstetrics and Gynecology Gynecologic Tumor Committee: Survey on Fertility-Sparing Treatment for Early stage Endometrial Cancer in Japan
Scientific Title:Acronym
Survey on Fertility-Sparing Treatment for Endometrial Cancer
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Recognize the current situation of fertility-sparing treatment for endometrial cancer, and propose the safe and effective treatment strategy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
National data of complete response rate of the end of fertility-sparing treatment
Key secondary outcomes
Frequency and grade of adverse event of the treatment, number of pregnancy and obstetrical prognosis after treatment
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
| Not applicable |
Gender
Female
Key inclusion criteria
Endometrial cancer patients who received fertility - sparing treated by the Japanese hospitals joining to the JSOG tumor committee and agreed to join this study.
Key exclusion criteria
Patients who has no indication of fertility sparing treatment. Patients who were already treated by the other hospitals.
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Ushijima |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
830-0011
Address
67 Asahi - machi Kurume
TEL
0942317573
kimi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Ushijima |
Organization
Kurume University School of Medicine Department of Obstetrics and Gynecology
Division name
Department of Obstetrics and Gynecology
Zip code
830-0011
Address
67 Asahi - machi Kurume
TEL
0942317573
Homepage URL
kimi@med.kurume-u.ac.jp
Sponsor or person
Institute
Japan Society of Obstetrics & Gynecology, Gynecologic Tumor Committee
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Obstetrics & Gynecology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Hospital Clinical Research Center
Address
67 Asahi machi, Kurume
Tel
0942-65-3749
i_rinri@kurume-u.ac.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
日本産科婦人科学会婦人科腫瘍登録施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.jsog.or.jp/
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
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
not decided
Management information
Registered date
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
