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
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
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
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 | |
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| Registered date | File name |
