UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032209
Receipt No. R000036736
Scientific Title Pilot study of photodynamic diagnosis with 5 aminolevulinic acid for Esophageal Cancer.
Date of disclosure of the study information 2018/04/12
Last modified on 2019/04/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pilot study of photodynamic diagnosis with 5 aminolevulinic
acid for Esophageal Cancer.
Acronym Pilot study of photodynamic diagnosis with 5 aminolevulinic
acid for Esophageal Cancer.
Scientific Title Pilot study of photodynamic diagnosis with 5 aminolevulinic
acid for Esophageal Cancer.
Scientific Title:Acronym Pilot study of photodynamic diagnosis with 5 aminolevulinic
acid for Esophageal Cancer.
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate optimal time from oral administration of 5 aminolevulinicacid to the photodynamic diagnosis for Esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Optimal time from oral administration of 5 aminolevulinicacid to the photodynamic diagnosis
Key secondary outcomes Adverse events due to oral administration of 5 aminolevulinicacid and photodynamic diagnostic equipments

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 Device,equipment
Interventions/Control_1 Take 5ALA 3-9 hours before the endoscopy
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 with esophageal cancer
Patient scheduled for endoscpic diagnosis.
Key exclusion criteria Pregnant women or possibly breast-feeding patients
Patients with photosensitivity, history of porphyria, or family history
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masakazu
Middle name
Last name Yamamoto
Organization Tokyo Women's Medical Universty
Division name Department of Surgery, Institute of Gastroenterology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email yamamoto.masakazu@twmu.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Kudo
Organization Tokyo Women's Medical Universty
Division name Department of Surgery, Institute of Gastroenterology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email kudo.ige@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical Universty
Institute
Department

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 IRB
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel 0333538111
Email inai.kiyoshi@twmu.ac.jp

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 東京女子医科大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 12 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 Terminated
Date of protocol fixation
2018 Year 04 Month 12 Day
Date of IRB
2018 Year 03 Month 31 Day
Anticipated trial start date
2018 Year 04 Month 12 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
2019 Year 04 Month 30 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2019 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036736

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.