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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005080
Receipt No. R000004397
Scientific Title Clinical research of diagnosis for lymph node metastases of gastrointestinal cancer by using 5-aminolevulinic acid
Date of disclosure of the study information 2011/02/14
Last modified on 2016/08/19

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Basic information
Public title Clinical research of diagnosis for lymph node metastases of gastrointestinal cancer by using 5-aminolevulinic acid
Acronym Clinical research of diagnosis for lymph node metastases by using 5-ALA
Scientific Title Clinical research of diagnosis for lymph node metastases of gastrointestinal cancer by using 5-aminolevulinic acid
Scientific Title:Acronym Clinical research of diagnosis for lymph node metastases by using 5-ALA
Region
Japan

Condition
Condition colorectal cancer, gastric cancer, esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the acurate diagnosis for gastrointestinal cancer by using 5-ALA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes evaluation of the diagnosis rate of the lymph node metastasis
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Oral administration of 5-aminolevulinic acid before surgery
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 gastrointeistinal cancer diagnosed before surgery
Key exclusion criteria Porphyria
Recipient of drugs inducing photosensitivity
Pregnant women and women suspected of being pregnant
Patients who did not agree with this study
Patients whom doctors decided as not a candidate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Takamatsu
Organization Kyoto prefectural University of Medicine
Division name Department of Medical Photonics
Zip code
Address 465 Kajii-cho Hirokoji Kawaramachi, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5322
Email ttakam@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Harada
Organization Kyoto prefectual University of Medicine
Division name Department of Pathology and Cell Regulation
Zip code
Address 465 Kajii-cho Hirokoji Kawaramachi, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5322
Homepage URL
Email yoharada@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural University of Medicine
Institute
Department

Funding Source
Organization Ushio Inc.
SBI pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 京都府立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 14 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
2009 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 06 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
2011 Year 02 Month 14 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004397

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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