UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010086 |
|---|---|
| Receipt number | R000011794 |
| Scientific Title | The efficacy of photodynamic diagnosis using 5-aminolevulinic acid for detection of gastric and colon tumors |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2017/08/31 12:49:06 |
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Basic information
Public title
The efficacy of photodynamic diagnosis using 5-aminolevulinic acid for detection of gastric and colon tumors
Acronym
Photodynamic diagnosis using 5-aminolevulinic acid
Scientific Title
The efficacy of photodynamic diagnosis using 5-aminolevulinic acid for detection of gastric and colon tumors
Scientific Title:Acronym
Photodynamic diagnosis using 5-aminolevulinic acid
Region
| Japan |
Condition
Condition
gastric tumor, colon tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the intesity of fluorescense and its distribution in the gastric and colonic tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
fluorescence intesity and distrbution in the tumors
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
5-aminolevulinic acid(5-ALA) 20mg/kg peroral administration once
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were referred to the hospital for treatment for stomach and colorectal tumors scheduled endoscopic resection
Key exclusion criteria
Patients with liver dysfunction
Hypersensitivity to porphyrins
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Nishikawa |
Organization
Yamaguchi university graduate school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
1-1-1 Minamikogushi Ube Yamaguchi
TEL
0836-22-2241
junnis@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Nishikawa |
Organization
Yamaguchi university graduate school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
1-1-1 Minamikogushi Ube, Japan
TEL
0836-22-2243
Homepage URL
junnis@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
SBI pharma
HOYA
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 03 | Month | 01 | 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
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | 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
| 2013 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011794
