UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041267 |
|---|---|
| Receipt number | 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 | 2023/12/11 13:53:00 |
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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
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
hiroaki.takahashi@j.iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
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
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047116
| Research Plan | |
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| 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 |
