UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035166 |
|---|---|
| Receipt number | R000040079 |
| Scientific Title | The effect of 5-Aminolevulinic Acid to diagnose the upper urinary tract tumor with retrograde intra-renal ureteroscopy |
| Date of disclosure of the study information | 2018/12/08 |
| Last modified on | 2018/12/07 10:23:53 |
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Basic information
Public title
The effect of 5-Aminolevulinic Acid to diagnose the upper urinary tract tumor with retrograde intra-renal ureteroscopy
Acronym
ALADER STUDY
Scientific Title
The effect of 5-Aminolevulinic Acid to diagnose the upper urinary tract tumor with retrograde intra-renal ureteroscopy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | TAKASHI YOSHIDA |
Organization
Kansai Medical University
Division name
Urology and surgery
Zip code
Address
Shin-machi, Hirakata-shi Osaka
TEL
81-06-6992-1001
yoshidtk@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKASHI YOSHIDA |
Organization
Kansai Medical University
Division name
Urology and Surgery
Zip code
Address
Shin-machi, Hirakata-shi Osaka
TEL
81-06-6992-1001
Homepage URL
yoshidtk@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
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
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040079
