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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039257
Receipt No. R000044761
Scientific Title Observation study of bacterial flora in thoracic cavity through pleurectomy/decortication
Date of disclosure of the study information 2020/01/26
Last modified on 2020/01/26

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Basic information
Public title Observation study of bacterial flora in thoracic cavity
Acronym Observation study of bacterial flora in thoracic cavity
Scientific Title Observation study of bacterial flora in thoracic cavity through pleurectomy/decortication
Scientific Title:Acronym Observation study of bacterial flora in thoracic cavity through pleurectomy/decortication
Region
Japan

Condition
Condition Malignant Pleural Mesothelioma
Classification by specialty
Infectious disease Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the change of bacterial flora in thoracic cavity after surgery
Basic objectives2 Others
Basic objectives -Others To investigate the association of bacterial flora between in oral cavity and thoracic cavity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of bacterial flora in thoracic cavity and oral cavity
Key secondary outcomes The matching rates bacterial culture test between in oral cavity and in thoracic cavity

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
99 years-old >=
Gender Male and Female
Key inclusion criteria Patient who scheduled pleurectomy/decortication for malignant pleural mesothelioma
20 years old or older
Obtained informed consent
Key exclusion criteria Complicated infectious disease
Under 20 years-old
Not obtained informed consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Hashimoto
Organization Hyogo College of Medicine
Division name Department of Thoracic Surgery
Zip code 6638501
Address 1-1 Mukogawa-cho Nishinomiya city
TEL 0798-45-6885
Email kogekogemasaki@gmail.com

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Hashimoto
Organization Hyogo College of Medicine
Division name Department of Thoracic Surgery
Zip code 6638501
Address 1-1 Mukogawa-cho Nishinomiya city
TEL 0798-45-6885
Homepage URL
Email kogekogemasaki@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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 Hyogo College of Medicine
Address 1-1 Mukogawa-cho Nishinomiya city
Tel 0798456885
Email kogekogemasaki@gmail.com

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
2020 Year 01 Month 26 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
2019 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 01 Month 26 Day
Last modified on
2020 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044761

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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