UMIN-CTR Clinical Trial

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
Email	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
Email	ryoeih@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020378