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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028135
Receipt No. R000032200
Scientific Title Role of microbiome and clock gene in pulmonary resection for the patients with lung tumor
Date of disclosure of the study information 2017/07/07
Last modified on 2017/07/07

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Basic information
Public title Role of microbiome and clock gene in pulmonary resection for the patients with lung tumor
Acronym Microbiome for the patients with lung tumor
Scientific Title Role of microbiome and clock gene in pulmonary resection for the patients with lung tumor
Scientific Title:Acronym Microbiome for the patients with lung tumor
Region
Japan

Condition
Condition Lung tumors
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the role of microbiome, inflammatory cytokines, and clock gene in patients undergoing pulmonary resection surgery
Basic objectives2 Others
Basic objectives -Others To evaluate the role of microbiome, inflammatory cytokines, and clock gene in patients undergoing pulmonary resection surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Expression analyses of microbiome, inflammatory cytokines, and clock gene in the patients with lung tumors
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Scheduled to receive pulmonary resection surgery.
2. Patients must be aged 20 years or older.
3. Written informed consent is provided by the patient.
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiyasu Takeuchi
Organization National Hospital Organization Toneyama Hospital
Division name General Thoracic Surgery
Zip code
Address 5-1-1 Toneyama, Toyonaka-City, Osaka
TEL 0668532001
Email ytakeuch@toneyama.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Hayashi
Organization National Hospital Organization Toneyama Hospital
Division name General Thoracic Surgery
Zip code
Address 5-1-1 Toneyama, Toyonaka-City, Osaka
TEL 0668532001
Homepage URL
Email ahayashi@toneyama.go.jp

Sponsor
Institute Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital
Institute
Department

Funding Source
Organization Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital
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 国立病院機構刀根山病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 07 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 07 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information None

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032200

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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