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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003209
Receipt No. R000003880
Scientific Title Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients
Date of disclosure of the study information 2010/03/01
Last modified on 2018/02/26

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Basic information
Public title Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients
Acronym CTLG with bronchoalveolar injection of iopamidol using ultrathin bronchoscope
Scientific Title Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients
Scientific Title:Acronym CTLG with bronchoalveolar injection of iopamidol using ultrathin bronchoscope
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 validity of computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope for preoperative lung cancer patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes detection rate 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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Computed tomography lymphography with bronchoalveolar injection of iopamidol using ultrathin bronchoscope
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria preoperative clinical stage IA patients
Key exclusion criteria high risk patients for curative operation, allergy to iodine
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromitsu Takizawa
Organization Tokushima University Hospital
Division name Department of Thoracic Surgery
Zip code
Address 3-18-15, Kuramotocho, Tokushima city, Tokushima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokushima Graduate School
Division name Department of Thoracic, Endocrine Surgery and Oncology
Zip code
Address
TEL
Homepage URL
Email htakizawa@clin.med.tokushima-u.ac.jp

Sponsor
Institute Department of Thoracic, Endocrine Surgery and Oncology, The University of Tokushima Graduate School
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
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 03 Month 01 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
2010 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 03 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
2010 Year 02 Month 18 Day
Last modified on
2018 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003880

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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