UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044365 |
|---|---|
| Receipt number | R000050677 |
| Scientific Title | Examination of reliability and validity of Japanese version CADS |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/05/31 11:41:59 |
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Basic information
Public title
Examination of reliability and validity of Japanese version CADS
Acronym
Examination of reliability and validity of Japanese version CADS
Scientific Title
Examination of reliability and validity of Japanese version CADS
Scientific Title:Acronym
Examination of reliability and validity of Japanese version CADS
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess psychometric validity and reliability of Japanese version of Chemotherapy-induced Alopecia Distress Scale(CADS).
Basic objectives2
Others
Basic objectives -Others
Validity and reliability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychometric validity and reliability of Japanese version of CADS
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
Female patients with breast cancer who are over 20 years old and agreed with informed consent.
Patients who are performed perioperative chemotherapy including anthracycline or taxane.
Patients with chemotherapy-induced alopecia.
Key exclusion criteria
Patients who have a history of chemotherapy-induced alopecia before.
Patients who are thought to be incompatible to join this study.
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Miura |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
yujmiura@mac.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Aoyama |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
yosuke.aoyama10@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Toranomon Hospital Institutional Review Board
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan
Tel
03-3588-1111
chikenjimukyoku@toranomon.gr.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
虎の門病院
関西医科大学附属病院
国立研究開発法人国立国際医療研究センター病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
132
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
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050677
| 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 |
