UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027807
Receipt number R000031432
Scientific Title The relationship between histologic subtypes of the endometrial stromal sarcoma and clinical features: A multi-institutional retrospective study
Date of disclosure of the study information 2017/06/22
Last modified on 2021/06/26 07:36:06

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Basic information

Public title

The relationship between histologic subtypes of the endometrial stromal sarcoma and clinical features: A multi-institutional retrospective study

Acronym

The relationship between histologic subtypes of the endometrial stromal sarcoma and clinical features: A multi-institutional retrospective study

Scientific Title

The relationship between histologic subtypes of the endometrial stromal sarcoma and clinical features: A multi-institutional retrospective study

Scientific Title:Acronym

The relationship between histologic subtypes of the endometrial stromal sarcoma and clinical features: A multi-institutional retrospective study

Region

Japan


Condition

Condition

endometrial stromal sarcoma

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the epidemiology, treatment and prognosis of endometrial stromal sarcoma by histologic subtypes in Japan.

Basic objectives2

Others

Basic objectives -Others

multi-institutional retrospective observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence, treatment and prognosis by histologic subtypes of endometrial stromal sarcoma in Japan.

Key secondary outcomes

Pathological prognostic 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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients who received initial treatment for endometrial stromal sarcoma from January 2002 through December 2012.

Key exclusion criteria

Patients with carcinosarcoma containing endometrial stromal sarcoma as sarcomatous element.
Patients whose pathological specimens cannot be used.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Aklira
Middle name
Last name Kikuchi

Organization

Niigata Cancer Center Hospital

Division name

Department of Gynecology

Zip code

951-8566

Address

2-15-3 Kawagishicho, Chuo-ku, Niigata City, 951-8566, Japan

TEL

025-266-5111

Email

akirak@niigata-cc.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Kikuchi

Organization

Niigata Cancer Center Hospital

Division name

Department of Gynecology

Zip code

951-8566

Address

2-15-3 Kawagishicho, Chuo-ku, Niigata City, 951-8566, Japan.

TEL

025-266-5111

Homepage URL


Email

akirak@niigata-cc.jp


Sponsor or person

Institute

JCOG gynecologic oncology group and cooperating institutions.

Institute

Department

Personal name



Funding Source

Organization

National cancer center Japan

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

Akira Kikuchi

Address

2-15-3 Kawagishicho, Chuo-ku, Niigata City, 951-8566, Japan.

Tel

025-266-5111

Email

akirak@niigata-cc.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 22 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

148

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

No longer recruiting

Date of protocol fixation

2016 Year 12 Month 12 Day

Date of IRB

2017 Year 05 Month 15 Day

Anticipated trial start date

2017 Year 01 Month 31 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

USB flash drive with Case Report form will be sent to each institution. After data entry, the USB flash drive and pathological materials for central pathological review will be sent to the Study Secretariat by courier. The identification of registered patients will be conducted using a case number consisting of institutional name and consecutive serial numbers. Personally identifiable information such as medical record number and initials will not be revealed to the Study Secretariat. The correspondence table will be kept at each institution and not sent to the Study Secretariat. Non-stained slides will be used for immunostaining and genetic test of tumor tissue.


Management information

Registered date

2017 Year 06 Month 19 Day

Last modified on

2021 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031432


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name