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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031205
Receipt No. R000035334
Scientific Title A prospective study evaluating efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Date of disclosure of the study information 2018/03/21
Last modified on 2018/01/22

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Basic information
Public title A prospective study evaluating efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Acronym efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Scientific Title A prospective study evaluating efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Scientific Title:Acronym efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy of ALA HCl for diagnosis of upper urinary tract urothelial carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rates of pathologically positive patients who were photodynamically positive.
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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Administration of ALA HCl 2-4 hours before ureterorenoscopy
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who will undergo ureterorenoscopy for
diagnosis of upper urinary tract urothelial carcinoma
Key exclusion criteria Patients with allergy to ALA HCl or porphyrin, light hypersensitivity
Patients with administration of the drugs which are contraindicated contraindication with ALA HCl
Pregnant or lactating woman
Patients with severe underlying diseases such as cardiovascular event, liver disfunction, diabetes mellitus, and so on.
Patients who have been enrolled into another study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Wada
Organization Okayama University Hospital
Division name Urology
Zip code
Address Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
TEL 086-235-7287
Email gmd17055@s.okadai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Wada
Organization Okayama University Hospital
Division name Urology
Zip code
Address Shikata-cho 2-5-1, Kita-ku, Okayama, Japan
TEL 086-235-7287
Homepage URL
Email gmd17055@s.okadai.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 08 Day
Last modified on
2018 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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