UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Photodynamic diagnosis for upper urinary tract carcinoma using 5-ALA
Title of the study (Brief title)	PDD for UUTC
Region	Japan

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

Objectives
Narrative objectives1	Discovery reseach
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive subject rates
Key secondary outcomes	Sensitivity, specificity

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	Photodynaminc diagnosis for upper urinary tract carcinoma after ALA administration. ALA: 20mg/kg
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. Age-lower limit; >20 year-old 2. Suspicious of upper urinary tract carcinoma 3. To agree informed concent 4. To sign agreement document
Key exclusion criteria	1. Hypersensitivity for ALA 2. Porphyria patients 3. Severe infectious disease 4. Severe complication
Target sample size	10

Research contact person
Name of lead principal investigator	Inoue Keiji
Organization	Kochi Medical School
Division name	Department of urology
Address	Oko, Nankoku, Kochi prefecture
TEL	088-880-2402
Email	keiji@kochi-u.ac.jp

Public contact
Name of contact person	Fukuhara Hideo
Organization	Kochi medical school
Division name	Department of urology
Address	Oko, Nankoku, Kochi prefecture
TEL	088-880-2402
Homepage URL
Email	jm-fukuhara@kochi-u.ac.jp

Sponsor
Institute	Kochi medical school, department of urology
Institute
Department

Funding Source
Organization	Kochi medical school, department of urology
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 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 26 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
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 03 Month 06 Day
Last modified on	2018 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036091