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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028625
Receipt No. R000032764
Scientific Title Analysis of of the prognostic value of histological subtypes in locally advanced adenocarcinoma of the uterine cervix after carbon-ion radiotherapy
Date of disclosure of the study information 2017/08/10
Last modified on 2017/10/02

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Basic information
Public title Analysis of of the prognostic value of histological subtypes in locally advanced adenocarcinoma of the uterine cervix after carbon-ion radiotherapy
Acronym Analysis of of the prognostic value of histological subtypes in locally advanced adenocarcinoma of the uterine cervix after carbon-ion radiotherapy
Scientific Title Analysis of of the prognostic value of histological subtypes in locally advanced adenocarcinoma of the uterine cervix after carbon-ion radiotherapy
Scientific Title:Acronym Analysis of of the prognostic value of histological subtypes in locally advanced adenocarcinoma of the uterine cervix after carbon-ion radiotherapy
Region
Japan

Condition
Condition Uterine cervical cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the evaluation of the prognostic value of histological subtypes in locally advanced adenocarcinoma of the uterine cervix after carbon-ion radiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 5-year overall survival rate
Key secondary outcomes 5-year local control rate
5-year disease-free survival rate

Base
Study type Others,meta-analysis etc

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

Not applicable
Gender Female
Key inclusion criteria They can be diagnosed for histological subtypes by pathologist.
Key exclusion criteria They can not be diagnosed for histological subtypes
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Wakatsuki
Organization Jichi medical University
Division name Department of Radiology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7161
Email masaru.wakatsuki@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Wakatsuki
Organization Jichi medical University
Division name Department of Radiology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7161
Homepage URL
Email masaru.wakatsuki@nifty.com

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 08 Month 10 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 Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a supplementary analysis for clinical trial of C-ion RT for locally advanced adenocarcinoma of the uterine cervix

Management information
Registered date
2017 Year 08 Month 10 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032764

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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