UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051013 |
|---|---|
| Receipt number | R000058154 |
| Scientific Title | Study on evaluation and prediction of dry skin, peripheral neuropathy, and hyperglycemia due to administration of enfortumab vedotin |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2023/05/09 09:18:49 |
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Basic information
Public title
Study on evaluation and prediction of dry skin, peripheral neuropathy, and hyperglycemia due to administration of enfortumab vedotin
Acronym
Study on evaluation and prediction of dry skin, peripheral neuropathy, and hyperglycemia due to administration of enfortumab vedotin
Scientific Title
Study on evaluation and prediction of dry skin, peripheral neuropathy, and hyperglycemia due to administration of enfortumab vedotin
Scientific Title:Acronym
Study on evaluation and prediction of dry skin, peripheral neuropathy, and hyperglycemia due to administration of enfortumab vedotin
Region
| Japan |
Condition
Condition
urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate and predict dry skin, peripheral neuropathy, and hyperglycemia caused by administration of enfortumab vedotin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At days 1, 15, 29, 43, 53, and 71 after the start of administration of enfortumab vedotin, blood and stratum corneum sampling by tape stripping will be performed.
And the following items will be evaluated.
1.Dry skin: transepidermal water loss (TEWL), stratum corneum intercellular lipids (ceramides, fatty acids, cholesterol)
2.Peripheral neuropathy: blood monomethyl auristatin E concentration, galectin 3 concentration
3.Hyperglycemia: sugar metabolites
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed unresectable urothelial carcinoma that has progressed after chemotherapy
2.Patients aged 20 years or older at the time of informed consent
3.Patients with ECOG Performance status of 0 or 1
4.Patients who have given written informed consent of their own free will after fully understanding their participation in this study.
5.Patients who are expected to survive for 3 months or more from the start date of the study.
Key exclusion criteria
1.Patients with a history of drug hypersensitivity that may interfere with this treatment.
2.Patients with uncontrolled serious complications.
3.Patients who are pregnant or may be pregnant.
4.Others deemed inappropriate by the attending physician.
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
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
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
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
4-63
Org. issuing International ID_1
University of Shizuoka
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 09 | 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
| 2023 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At Days 1, 15, 29, 43, 53, and 71 after the start of administration of enfortumab vedotin, blood and stratum corneum sampling by tape stripping will be performed.
And the following items will be evaluated.
1.Dry skin: transepidermal water loss (TEWL), stratum corneum intercellular lipids (ceramides, fatty acids, cholesterol)
2.Peripheral neuropathy: blood monomethyl auristatin E concentration, galectin 3 concentration
3.Hyperglycemia: sugar metabolites
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058154
| 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 |
