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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041267
Receipt No. R000047116
Scientific Title A prospective clinical study concerning the quantitative evaluation of skin disorders caused by molecular-targeted agents
Date of disclosure of the study information 2020/07/31
Last modified on 2020/08/20

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Basic information
Public title A prospective clinical study concerning the quantitative evaluation of skin disorders caused by molecular-targeted agents
Acronym An observational study toward the prediction of skin disorders caused by anti-EGFR antibody drugs and their clinical application
Scientific Title A prospective clinical study concerning the quantitative evaluation of skin disorders caused by molecular-targeted agents
Scientific Title:Acronym An observational study toward the prediction of skin disorders caused by anti-EGFR antibody drugs and their clinical application
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to predict the severity of skin disorders caused by anti-EGFR antibody drugs and establish ways to avoid them by quantitatively evaluating the changes in skin conditions (transepidermal water loss, etc.) caused by these drugs and elucidating the relationship between skin conditions and skin disorders.
Basic objectives2 Others
Basic objectives -Others To measure the changes in skin conditions (transepidermal water loss, etc.) over time
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between skin conditions and skin disorders caused by anti-EGFR antibody drugs
Key secondary outcomes Analysis of the changes in skin conditions and risk factors for the manifestation of skin disorders after anti-EGFR antibody drug use

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 Male and Female
Key inclusion criteria Patients who meet all of the following conditions may participate in this study:
1) A male and female patient older than 20 years
2) A patient diagnosed with cancer
3) A patient who will receive anti-EGFR antibody drugs for the first time as cancer treatment
4) A patient who can provide written consent to participate in this study
Key exclusion criteria Patients who meet any of the following conditions will be excluded from the study:
1) A patient with a skin disease such as psoriasis or atopic dermatitis
2) A patient deemed unfit to participate by the doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kenzo
Middle name
Last name Kudo
Organization School of Pharmacy, Iwate Medical University
Division name Department of Clinical Pharmacy, Division of Clinical Pharmaceutics and Pharmacy Practice
Zip code 028-3694
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3694, Japan
TEL +81-19-651-5111
Email kenzkudo@iwate-med.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Takahashi
Organization School of Pharmacy, Iwate Medical University
Division name Department of Clinical Pharmacy, Division of Clinical Pharmaceutics and Pharmacy Practice
Zip code 028-3694
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3694, Japan
TEL +81-19-651-5111
Homepage URL
Email hiroaki.takahashi@j.iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee of Iwate Medical University School of Medicine
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3694, Japan
Tel +81-19-651-5111
Email kenkyu-rinri@j.iwate-med.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
2020 Year 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 22 Day
Date of IRB
2018 Year 01 Month 04 Day
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients will be assigned into two groups according to the extent of skin disorders, and the skin conditions will be compared between patients in each group to examine the relationship between skin disorders and skin conditions.

Management information
Registered date
2020 Year 07 Month 31 Day
Last modified on
2020 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047116

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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