UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025757 |
|---|---|
| Receipt number | R000020378 |
| Scientific Title | evaluation of serum carnitine concentration in patients with urological malignancy and the effect of levocarnitine to them |
| Date of disclosure of the study information | 2017/01/21 |
| Last modified on | 2022/06/13 16:33:23 |
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Basic information
Public title
evaluation of serum carnitine concentration in patients with urological malignancy and the effect of levocarnitine to them
Acronym
the effect of levocarnitine to patients with urological malignancy
Scientific Title
evaluation of serum carnitine concentration in patients with urological malignancy and the effect of levocarnitine to them
Scientific Title:Acronym
the effect of levocarnitine to patients with urological malignancy
Region
| Japan |
Condition
Condition
Oncology
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Measurement and replenishment of carnitine concentration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of carnitine concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carnitine
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) urothelial carcinoma, prostate cancer, kidney carcinoma and testicular tumor disease
(2) Patients scheduled for chemotherapy treatment
Key exclusion criteria
(1) A person who falls under the administration contraindication
(2) Persons undergoing dialysis, those with advanced renal dysfunction
(3) Those who did not finally obtain consent
(4) Others that other medical doctor deems inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryoei |
| Middle name | |
| Last name | Hara |
Organization
Kawasaki Medical School
Division name
Urology
Zip code
710-0192
Address
Matsushima 577, Kurashiki City
TEL
086-462-1111
ryoeih@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Ryoei |
| Middle name | |
| Last name | Hara |
Organization
Kawasaki Medical School
Division name
Urology
Zip code
710-0192
Address
Matsushima 577, Kurashiki City
TEL
086-462-1111
Homepage URL
ryoeih@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
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
Kawasaki Medical School
Address
Matsushima 577, Kurashiki City
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
| 2017 | Year | 01 | Month | 21 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020378
| 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 |
