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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038789
Receipt No. 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

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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
Obsterics 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
Email 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
Email nho.kmc.rc@hotmail.com

Sponsor
Institute Clinical Research Center, NHO Kyoto Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044182

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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