UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of 5-Aminolevulinic Acid to diagnose the upper urinary tract tumor with retrograde intra-renal ureteroscopy
Title of the study (Brief title)	ALADER STUDY
Region	Japan

Condition
Condition	Upper tract urinary tumor UTUC
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of 5ALA for upper tarct urinary tumor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity
Key secondary outcomes	Specifity

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	preoperative oral medicine of 5ALA
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	The following are inclusion criteria a, suspect of UTUC for imaging study(CT, MRI, IVP, RP) and negative urinary cytology b, suspect of UTUC for negative bladder tumor and positive urinary cytology c, Undergoing ureteroscopic treatment for UTUC
Key exclusion criteria	The following are exclusion criteria 1) patient with positive imaging finding and positive urinary cytology 2) patient with porphyrine allegery 3) patient with 5ALA allegery
Target sample size	20

Research contact person
Name of lead principal investigator	TAKASHI YOSHIDA
Organization	Kansai Medical University
Division name	Urology and surgery
Address	Shin-machi, Hirakata-shi Osaka
TEL	81-06-6992-1001
Email	yoshidtk@takii.kmu.ac.jp

Public contact
Name of contact person	TAKASHI YOSHIDA
Organization	Kansai Medical University
Division name	Urology and Surgery
Address	Shin-machi, Hirakata-shi Osaka
TEL	81-06-6992-1001
Homepage URL
Email	yoshidtk@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
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)

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	2018 Year 12 Month 08 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 07 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040079