UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041159 |
|---|---|
| Receipt number | R000047007 |
| Scientific Title | Analysis of composition and structure of stratum corneum after capecitabine administration |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2020/07/20 12:47:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of composition and structure of stratum corneum after capecitabine administration
Acronym
Analysis of composition and structure of stratum corneum after capecitabine administration
Scientific Title
Analysis of composition and structure of stratum corneum after capecitabine administration
Scientific Title:Acronym
Analysis of composition and structure of stratum corneum after capecitabine administration
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the composition and structure of the stratum corneum components of hand-foot syndrome (HFS) induced by capecitabine and evaluate the relationship with clinical symptoms of HFS
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of Composition and structure of stratum corneum components with clinical symptom
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients receiving adjuvant chemotherapy for colorectal cancer at the Medical Oncology of Shizuoka General Hospital
2. More than 20-years olds patients at the time of enrollement
Key exclusion criteria
1. Patients with a history of allergy for this treatment
2. Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomonobu |
| Middle name | |
| Last name | Uchino |
Organization
University of Shizuoka
Division name
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
+81-54-264-5771
uchinot@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Tomonobu |
| Middle name | |
| Last name | Uchino |
Organization
University of Shizuoka
Division name
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
+81-54-264-5771
Homepage URL
uchinot@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Shizuoka general hospital
Address
4-27-1 kitaando aoi-ku shizuoka-shi Shizuoka, Japan
Tel
054-247-6111
chiken-sougou@shizuoka-pho.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
SGHIRB#2019098
Org. issuing International ID_1
Shizuoka general hospital
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 | 20 | 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
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The transepidermal water loss (TEWL) of the patient will be measured on Day 22, 43, 64, and 85 from the start of taking capecitabine.
On the same day, 5th stratum corneum of the palm is sampled by tape stripping method, and the compoments and strcture of stratum corneum structure are analyzed.
Association of the result of analysis data with clinical symptom will be investigated.
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2020 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
