UMIN-CTR Clinical Trial

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
Email	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
Email	hideya10@hotmail.com

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011191