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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015624
Receipt No. R000018154
Scientific Title Current Status of Recurrence after Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan: A Retrospective Analysis
Date of disclosure of the study information 2014/11/06
Last modified on 2018/05/11

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Basic information
Public title Current Status of Recurrence after Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan:
A Retrospective Analysis
Acronym Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan
Scientific Title Current Status of Recurrence after Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan:
A Retrospective Analysis
Scientific Title:Acronym Secondary Debulking Surgery for Recurrent Mullerian Epithelial Cancer in Japan
Region
Japan

Condition
Condition Mullerian Epithelial Cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate of overall survival after secondary debulking surgery.
Basic objectives2 Others
Basic objectives -Others To investigate current status of recurrence after secondary debulking surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 Cases which became complete response between January, 2000 to September, 2014. And the cases recurrenced.
Key exclusion criteria Cases which they did not became complete response after recurrence.
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomoko Hirakawa
Organization Oita University, Oita, Japan
Division name Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address Idaigaoka 1-1, Hasama-machi, Yufu-shi, Oita 879-5593, Japan
TEL 097-586-5922
Email tomokoh@oita-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomoko Hirakawa
Organization Oita University, Oita, Japan
Division name Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address Idaigaoka 1-1, Hasama-machi, Yufu-shi, Oita 879-5593, Japan
TEL 097-586-5922
Homepage URL
Email tomokoh@oita-u.ac.jp

Sponsor
Institute KCOG
Institute
Department

Funding Source
Organization KCOG
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 KCOG-G1402
Org. issuing International ID_1 KCOG-G1402
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 07 Day
Last follow-up date
2016 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information Not yet

Management information
Registered date
2014 Year 11 Month 07 Day
Last modified on
2018 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018154

Research Plan
Registered date File name
2016/11/08 KCOG-G1402プロトコール2015年04月.doc

Research case data specifications
Registered date File name
2016/11/08 KCOG-G1402プロトコール2015年04月.doc

Research case data
Registered date File name
2016/11/08 Fig 2.pptx


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