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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034254
Receipt No. 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 2018/09/25

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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
Obsterics 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
Middle name
Last name Kimio Ushijima
Organization Kurume University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 67 Asahi - machi Kurume
TEL 0942-31-7573
Email kimi@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimio Ushijima
Organization Kurume University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 67 Asahi - machi Kurume
TEL 0942-31-7573
Homepage URL
Email kimi@med.kurume-u.ac.jp

Sponsor
Institute Japan Society of Obstetrics & Gynecology, Gynecologic Tumor Committee
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 21 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information not decided

Management information
Registered date
2018 Year 09 Month 25 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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