UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of photodynamic diagnosis using 5ALA for early head and neck or gastrointestinal cancer
Acronym	Feasibility study of 5ALA-PDD
Scientific Title	Feasibility study of photodynamic diagnosis using 5ALA for early head and neck or gastrointestinal cancer
Scientific Title:Acronym	Feasibility study of 5ALA-PDD
Region	Japan

Condition
Condition	early head and neck or gastrointestinal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility of photodynamic diagnosis using 5ALA for early head and neck or gastrointestinal cancer by photodynamic diagnosis for resected these specimens.
Basic objectives2	Others
Basic objectives -Others	Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concordance rate between fluorescence intensity and pathological findings
Key secondary outcomes	Adverse events Tissue damage by laser.

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	5ALA is administered orally 3 hours before EMR/ESD.
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	1) EMR or ESD is scheduled for following i) or ii) cancer. i. Tis-T2, N0, M0 oropharynx or hypopharynx cancer ii. T1, N0, M0 esophagus, stomach ,or colon cancer 2) >= 20 years old. 3) ECOG performance status of <= 1. 4) No prior radiation for cancer in the target organ. 5) Adequate organ function. 6) Written informed consent.
Key exclusion criteria	1) A history of photosensitivity. 2) Porphyria. 3) Women during pregnancy or breast-feeding. 4) Cirrhosis, acute or chronic hepatitis. 5) Systemic treatment is indicated for bacterial or fungal infection. 6) Positive HBs antigen, HCV antibody or known positive serology for HIV. 7) Patient is judged to be inappropriate for study participation for any reason by the investigator.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomonori Yano
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	toyano@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Tomoji Kato
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	tomkato@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	drug supply : SBI Pharmaceuticals Co., Ltd. device supply : FUJIFILM Corporation
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	国立がん研究センター東病院（千葉県）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 07 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	Completed
Date of protocol fixation	2012 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 07 Day
Last follow-up date	2015 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	2012 Year 09 Month 07 Day
Last modified on	2014 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010314

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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