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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027807
Receipt No. 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 2018/12/20

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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
Obsterics 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
Middle name
Last name Akira Kikuchi
Organization Niigata Cancer Center Hospital
Division name Department of Gynecology
Zip code
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
Middle name
Last name Akira Kikuchi
Organization Niigata Cancer Center Hospital
Division name Department of Gynecology
Zip code
Address 2-15-3 Kawagishicho, Chuo-ku, Niigata City, 951-8566, Japan.
TEL 025-266-5111
Homepage URL
Email akirak@niigata-cc.jp

Sponsor
Institute JCOG gynecologic oncology group and cooperating institutions.
Institute
Department

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
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

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
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
2016 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 31 Day
Last follow-up date
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
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.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


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