UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021288 |
|---|---|
| Receipt number | R000024556 |
| Scientific Title | Photodynamic diagnosis of gastric cancer and esophageal cancer using fluorescence diagnosis with 5-aminolevulinic acid (5-ALA) |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/02 17:21:05 |
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Basic information
Public title
Photodynamic diagnosis of gastric cancer and esophageal cancer using fluorescence diagnosis with 5-aminolevulinic acid (5-ALA)
Acronym
Photodynamic diagnosis of gastric cancer and esophageal cancer using fluorescence diagnosis with 5-aminolevulinic acid (5-ALA)
Scientific Title
Photodynamic diagnosis of gastric cancer and esophageal cancer using fluorescence diagnosis with 5-aminolevulinic acid (5-ALA)
Scientific Title:Acronym
Photodynamic diagnosis of gastric cancer and esophageal cancer using fluorescence diagnosis with 5-aminolevulinic acid (5-ALA)
Region
| Japan |
Condition
Condition
gastric cancer, esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of the photodynamic diagnosis (PDD) of gastric cancer and esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy
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) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50mL of 5% glucose solution.
5-ALA solution was administered either way of following:
Orally(1.0g/50mL); 180-240minutes before operation
Instilled intravesically(1.5g/50mL); 90-120 minutes before operation.
For fluorescence excitation a blue light source was used.
Under white and fluorescence light guidance outputted by light source apparatus (D-Light AF System) and videocamera system (Endovision TELECAM SL/IPM-PPD System), tumor locations were recorded, cold cup biopsies were taken and tumors were resected.
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
patient who was diagnosed as gastric cancer or esophageal cancer.
Key exclusion criteria
patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2,E2
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahashi Tsuyoshi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-15 Yamadaoka, Suita, Osaka,565-0871,Japan
TEL
+81-6-6879-3251
Homepage URL
ttakahashi2@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
None
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
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2016 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024556
