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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021288
Receipt No. 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

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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
Email 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
Email ttakahashi2@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024556

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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