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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006091
Receipt No. R000007207
Scientific Title Clinical study on the detection system for intraoperative sentinel lymph node used to ICG in Gastric Cancer
Date of disclosure of the study information 2011/08/02
Last modified on 2011/08/01

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Basic information
Public title Clinical study on the detection system for intraoperative sentinel lymph node used to ICG in Gastric Cancer
Acronym Clinical study on sentinel lymph node detection system
Scientific Title Clinical study on the detection system for intraoperative sentinel lymph node used to ICG in Gastric Cancer
Scientific Title:Acronym Clinical study on sentinel lymph node detection system
Region
Japan

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

Objectives
Narrative objectives1 Reduction of the lymph node dissection in gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Histopathologic diagnosis of lymph node dissection, sentinel lymph node-positive rate,Range of validity of dissection
Key secondary outcomes Short-term postoperative outcome

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 ICG
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 gastric cancer patient
possible oral intake
PS0,1 patient
Key exclusion criteria majior complication patient
liver chirrosis patient
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Shimada
Organization University of Tokushima
Division name Department of Surgery
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Kurita,
Organization University of Tokushima
Division name Department of Surgery
Zip code
Address
TEL 088-631-3111
Homepage URL
Email

Sponsor
Institute University of Tokushima
Institute
Department

Funding Source
Organization University of Tokushima
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 02 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 Preinitiation
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 01 Day
Last modified on
2011 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007207

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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