UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011052 |
|---|---|
| Receipt number | R000012935 |
| Scientific Title | Multi-center Clinico-pathological study of Uterine Papillary Serous Carcinoma of Japan |
| Date of disclosure of the study information | 2013/06/28 |
| Last modified on | 2019/12/31 16:49:33 |
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Basic information
Public title
Multi-center Clinico-pathological study of Uterine Papillary Serous Carcinoma of Japan
Acronym
UPSC Japan study
Scientific Title
Multi-center Clinico-pathological study of Uterine Papillary Serous Carcinoma of Japan
Scientific Title:Acronym
UPSC Japan study
Region
| 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 make standard treatment strategy of uterine papillary serous carcinoma by investigating epidemiology, treatment and results of this disease.
Basic objectives2
Others
Basic objectives -Others
Investigate the accuracy of institutional pathological diagnosis.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The treatment strategy and treatment result of Japanese institutions.
Key secondary outcomes
Diagnostic agreement between institutional and central pathological review.
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 diagnosed UPSC by surgery between January 2006 and December 2008, including serous carcinoma in endometrial polyp.
Key exclusion criteria
Patients did not receive tumor resection by surgery.
Patients with active synchronous cancer.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimio Ushijima |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
Address
67 Asahi machi, Kurume
TEL
0942-31-7573
kimi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimio Ushijima |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics & Gynecology
Zip code
Address
67 Asahi machi, Kurume
TEL
0942-31-7573
Homepage URL
kimi@med.kurume-u.ac.jp
Sponsor or person
Institute
JCOG gynecologic oncology group
Institute
Department
Personal name
Funding Source
Organization
National cancer center research and development fund 23-A-17
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
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
JCOG婦人科腫瘍グループの各施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 28 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 01 | Day |
Other
Other related information
This is a multi-center retrospective study.
Management information
Registered date
| 2013 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012935
