UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010960
Receipt number R000012828
Scientific Title A multi-institutional retrospective analysis of uterine carcinosarcoma
Date of disclosure of the study information 2013/06/15
Last modified on 2013/06/14 11:46:43

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Basic information

Public title

A multi-institutional retrospective analysis of uterine carcinosarcoma

Acronym

retrospective analysis of uterine carcinosarcoma

Scientific Title

A multi-institutional retrospective analysis of uterine carcinosarcoma

Scientific Title:Acronym

retrospective analysis of uterine carcinosarcoma

Region

Japan


Condition

Condition

Uterine Carcinosarcoma

Classification by specialty

Hematology and clinical oncology Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of the retrospective analysis is to clarify the actual treatments and outcome of uterine carcinosarcoma, and to analize the prognostic factors.

Basic objectives2

Others

Basic objectives -Others

To analize the actual surgical, radiation, and chemotherapy outcome, and to clarify the prognostic factors influencing the treatment outcome.

Trial characteristics_1

Others

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

actual treatment and outcome

Key secondary outcomes

patient characteristics and pathological factors


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

patients who are newly, pathologically diagnosed as FIGO stage I-IV uterine carcinosarcoma

Key exclusion criteria

carcinosarcoma of ovary
recurrent uterinecarcinosarcoma

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Harano

Organization

Nippin MedicalSchool Musashikosugi Hospital

Division name

Department of Medical Oncology

Zip code


Address

1-396, Kosugi-cho, Nakahara-ku, Kawasaki City, Kanagawa

TEL

044-733-5181

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Sawada

Organization

Japanese Gynecologic ONcology Group

Division name

Uterine Cancer committee

Zip code


Address

6-22-4F, Kagurazaka, Shinjuku-ku, Tokyo

TEL

03-5206-1982

Homepage URL

http://www.jgog.gr.jp/clinical_testing/clinical_testing.html

Email

sawada@jgog.gr.jp


Sponsor or person

Institute

Japanese Gynecologic Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Japanese Gynecologic Oncology Group

Organization

Division

Category of Funding Organization

Non profit foundation

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

日本婦人科悪性腫瘍研究機構加盟施設


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 15 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

Enrolling by invitation

Date of protocol fixation

2012 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2013 Year 09 Month 30 Day

Date of closure to data entry

2013 Year 09 Month 30 Day

Date trial data considered complete

2013 Year 09 Month 30 Day

Date analysis concluded

2013 Year 10 Month 31 Day


Other

Other related information

Now in enrolling cases


Management information

Registered date

2013 Year 06 Month 14 Day

Last modified on

2013 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012828


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name