UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015624
Receipt number 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 15:33:42

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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

Obstetrics 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

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

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 or person

Institute

KCOG

Institute

Department

Personal name



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

Value
https://center6.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