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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021850
Receipt No. R000025195
Scientific Title Flow cytometry analysis of hilum and mediastinum lymphadenopathy taken by EBUS-TBNA
Date of disclosure of the study information 2016/04/10
Last modified on 2017/04/15

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Basic information
Public title Flow cytometry analysis of hilum and mediastinum lymphadenopathy taken by EBUS-TBNA
Acronym Flow cytometry analysis of hilum and mediastinum lymphadenopathy taken by EBUS-TBNA
Scientific Title Flow cytometry analysis of hilum and mediastinum lymphadenopathy taken by EBUS-TBNA
Scientific Title:Acronym Flow cytometry analysis of hilum and mediastinum lymphadenopathy taken by EBUS-TBNA
Region
Japan

Condition
Condition Hilum and mediastinum lymphadenopathy
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of the immunocytic population in the lymph node
Basic objectives2 Others
Basic objectives -Others correlation between immunocytic population in the lymph node and disease prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of immune cell ratio in the lymph node,and disease prognosis
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 Collection of the specimen by EBUS-TBNA
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
90 years-old >
Gender Male and Female
Key inclusion criteria The case who have mediastinumand hilum lymphadenopathy.
Key exclusion criteria The case that an agreement was not provided
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Imaizumi
Organization Fujita Health University School of Medicine
Division name Division of Respiratory Medicine and Clinical Allergy
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL 0562-93-9241
Email jeanluc@fujita-hu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomoyuki Minezawa
Organization Fujita Health University School of Medicine
Division name Division of Respiratory Medicine and Clinical Allergy
Zip code
Address Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL 0562-93-9241
Homepage URL
Email minezawa@fujita-hu.ac.jp

Sponsor
Institute Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
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
2016 Year 04 Month 10 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 10 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
2016 Year 04 Month 10 Day
Last modified on
2017 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025195

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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