UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016005 |
|---|---|
| Receipt number | R000018606 |
| Scientific Title | The impact of the mode of adjuvant therapy on intermediate-risk and high-risk uterine endometrial cancer: A retrospective multicenter study |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2014/12/19 15:23:41 |
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Basic information
Public title
The impact of the mode of adjuvant therapy on intermediate-risk and high-risk uterine endometrial cancer: A retrospective multicenter study
Acronym
uterine endometrial adjuvant therapy study
Scientific Title
The impact of the mode of adjuvant therapy on intermediate-risk and high-risk uterine endometrial cancer: A retrospective multicenter study
Scientific Title:Acronym
uterine endometrial adjuvant therapy study
Region
| Japan | Asia(except 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 estimate standard adjuvant strategy of intermediate- and high-risk uterine endometrial cancer by investigating epidemiology, treatment, and outcome of the disease in Japan and China.
Basic objectives2
Others
Basic objectives -Others
to estimate standard adjuvant strategy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Local failure rate and distant failure rate
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 with intermediate-risk and high-risk uterine endometrial cancer who underwent operation at the participanting hospitals between January 1, 1996 to December 31, 2013.
Key exclusion criteria
Patients with incomplete clinicopathological data. Patients with more thean 1 primary tumor.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Tabata |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174, Edobashi, Tsu city, Mie, Japan
TEL
059-232-1111
tabatat@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayu Omori |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174, Edobashi, Tsu city, Mie, Japan
TEL
059-232-1111
Homepage URL
mayu-o@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
KCOG and Endometrial Cancer Program of Fudan University Shanghai Cancer Center
Institute
Department
Personal name
Funding Source
Organization
KCOG and Endometrial Cancer Program of Fudan University Shanghai Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan, Asia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
NPO法人 関西臨床腫瘍研究会（ＫＣＯＧ）、Endometrial Cancer Program of Fudan University Shanghai Cancer Center
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
multi-center retrospective study
Management information
Registered date
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018606
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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