UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028602 |
|---|---|
| Receipt number | R000011191 |
| Scientific Title | Development of objective analysis of radiation dermatitis |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/08/11 09:58:37 |
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Basic information
Public title
Development of objective analysis of radiation dermatitis
Acronym
Development of objective analysis of radiation dermatitis
Scientific Title
Development of objective analysis of radiation dermatitis
Scientific Title:Acronym
Development of objective analysis of radiation dermatitis
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develpment a quantitative analysis of radiation dermatitis breast-conserving therapy
Basic objectives2
Others
Basic objectives -Others
quantitative analysis of radiation dermatitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
objective and quatitative analysis of dermatitis after breast-conserving therapy
Key secondary outcomes
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
| Not applicable |
Gender
Female
Key inclusion criteria
breast cancer patients who are undergoing adjuvant radiotherapy after beast-conserving surgery
Key exclusion criteria
nothing particular
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideya |
| Middle name | |
| Last name | Yamazaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
602-0841
Address
465 Kajiicho, Kawaramachi Hirokoji,Kamigyo-ku, Kyoto, JAPAN
TEL
052-51-5111
hideya10@hotamil.com
Public contact
Name of contact person
| 1st name | Hideya |
| Middle name | |
| Last name | Yamazaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Radiology
Zip code
602-0841
Address
465 Kajiicho, Kawaramachi Hirokoji,Kamigyo-ku, Kyoto, JAPAN
TEL
075-251-5620
Homepage URL
hideya10@hotmail.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Kyoto Pref. Medical School
Address
Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Tel
075-251-5111
rinri@koto.kpu-m.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Over 70 patients registered in this study.
Awaiting for Analysis
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011191
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
