UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038789 |
|---|---|
| Receipt number | R000044182 |
| Scientific Title | A Study to Establish Method of Prognostic Prediction for Uterine Mesenchymal Tumor by Immunohistological Biomarkers |
| Date of disclosure of the study information | 2019/12/04 |
| Last modified on | 2019/12/04 14:18:04 |
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Basic information
Public title
A Study to Establish Method of Prognostic Prediction for Uterine Mesenchymal Tumor by Immunohistological Biomarkers
Acronym
PRUM-IBio study
Scientific Title
A Study to Establish Method of Prognostic Prediction for Uterine Mesenchymal Tumor by Immunohistological Biomarkers
Scientific Title:Acronym
PRUM-IBio study
Region
| Japan |
Condition
Condition
NR
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
NR
Basic objectives2
Others
Basic objectives -Others
NR
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NR
Key secondary outcomes
NR
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
NR
Key exclusion criteria
NR
Target sample size
390
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Hayashi |
Organization
NHO Kyoto Medical Center
Division name
Cancer Medicine
Zip code
612-8555
Address
1-1 Mukai-batakecho, Fukakusa, Fushimiku, Kyoto City, Kyoto
TEL
075-641-9161
nho.kmc.rc@hotmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Hayashi |
Organization
NHO Kyoto Medical Center
Division name
Cancer Medicine
Zip code
612-8555
Address
1-1 Mukai-batakecho, Fukakusa, Fushimiku, Kyoto City, Kyoto
TEL
075-641-9161
Homepage URL
nho.kmc.rc@hotmail.com
Sponsor or person
Institute
Clinical Research Center, NHO Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
NR
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
NR
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21, Higashi-ga-oka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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
国立病院機構所属医療機関（全国）、東北婦人科がんユニット（東北）、東京大学（東京都）、国立がん研究センター（東京都）、慶応義塾大学（東京都）、飯田市立病院（長野県）、京都大学（京都府）、近畿大学（大阪府）、大阪市立大学（大阪府）、大阪市立総合医療センター（大阪府）、九州大学（福岡県）、熊本大学（熊本県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 04 | 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
390
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
| 2019 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NR
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044182
