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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003035
Receipt No. R000003655
Scientific Title Intraoperative detection of sentinel lymph nodes in lung cancer
Date of disclosure of the study information 2010/01/16
Last modified on 2018/01/21

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Basic information
Public title Intraoperative detection of sentinel lymph nodes in lung cancer
Acronym Intraoperative detection of sentinel lymph nodes in lung cancer
Scientific Title Intraoperative detection of sentinel lymph nodes in lung cancer
Scientific Title:Acronym Intraoperative detection of sentinel lymph nodes in lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aims are to determine sentinel lymph node identification rate using indocyanine green fluorescence imaging system in patients with lung cancer and to evaluate the accuracy of sentinel lymph node for the presence of mediastino-hilar metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pathological examination of sentinel lymph node
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Indocyanine green
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
75 years-old >
Gender Male and Female
Key inclusion criteria patients with lung cancer who undergo pulmonary resection and mediastinal lymph node dissection
Key exclusion criteria patients with iodine allergy or pregnant women
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Higashiyama
Organization Osaka International Cancer Institute
Division name Department of Thoracic Surgery
Zip code
Address 3-1-69, Ootemae, Chuou-ku, Osaka
TEL 06-6945-1181
Email higasiyama-ma@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiteru Tokunaga
Organization Osaka International Cancer Institute
Division name Department of Thoracic Surgery
Zip code
Address 3-1-69, Ootemae, Chuou-ku, Osaka
TEL 06-6945-1181
Homepage URL
Email tokunaga4615@yahoo.co.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization self funding
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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 16 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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 04 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
2010 Year 01 Month 14 Day
Last modified on
2018 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003655

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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