UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028625 |
|---|---|
| Receipt number | 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 23:34:11 |
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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
| Obstetrics 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
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
masaru.wakatsuki@nifty.com
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032764
