UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011052
Receipt number R000012935
Scientific Title Multi-center Clinico-pathological study of Uterine Papillary Serous Carcinoma of Japan
Date of disclosure of the study information 2013/06/28
Last modified on 2019/12/31 16:49:33

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Basic information

Public title

Multi-center Clinico-pathological study of Uterine Papillary Serous Carcinoma of Japan

Acronym

UPSC Japan study

Scientific Title

Multi-center Clinico-pathological study of Uterine Papillary Serous Carcinoma of Japan

Scientific Title:Acronym

UPSC Japan study

Region

Japan


Condition

Condition

Endometrial cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to make standard treatment strategy of uterine papillary serous carcinoma by investigating epidemiology, treatment and results of this disease.

Basic objectives2

Others

Basic objectives -Others

Investigate the accuracy of institutional pathological diagnosis.

Trial characteristics_1

Others

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The treatment strategy and treatment result of Japanese institutions.

Key secondary outcomes

Diagnostic agreement between institutional and central pathological review.


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

Patients diagnosed UPSC by surgery between January 2006 and December 2008, including serous carcinoma in endometrial polyp.

Key exclusion criteria

Patients did not receive tumor resection by surgery.
Patients with active synchronous cancer.

Target sample size

200


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 & 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 & Gynecology

Zip code


Address

67 Asahi machi, Kurume

TEL

0942-31-7573

Homepage URL


Email

kimi@med.kurume-u.ac.jp


Sponsor or person

Institute

JCOG gynecologic oncology group

Institute

Department

Personal name



Funding Source

Organization

National cancer center research and development fund 23-A-17

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

JCOG婦人科腫瘍グループの各施設


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 28 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

Main results already published

Date of protocol fixation

2012 Year 01 Month 31 Day

Date of IRB

2011 Year 12 Month 19 Day

Anticipated trial start date

2013 Year 02 Month 11 Day

Last follow-up date

2015 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2016 Year 08 Month 31 Day

Date analysis concluded

2018 Year 09 Month 01 Day


Other

Other related information

This is a multi-center retrospective study.


Management information

Registered date

2013 Year 06 Month 26 Day

Last modified on

2019 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012935


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name