UMIN-CTR Clinical Trial

Basic information
Public title	Characterization of gut microbiome in patients with lung adenocarcinoma
Acronym	Characterization of gut microbiome in patients with lung adenocarcinoma
Scientific Title	Characterization of gut microbiome in patients with lung adenocarcinoma
Scientific Title:Acronym	Characterization of gut microbiome in patients with lung adenocarcinoma
Region	Japan

Condition
Condition	lung adenocarcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the relationship between gut microbiome and lung adenocarcinoma
Basic objectives2	Others
Basic objectives -Others	To assess the relationship between gut microbiome and lung adenocarcinoma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gut microbiome
Key secondary outcomes	none

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	patients with lung adenocarcinoma who agree to this study.
Key exclusion criteria	patients who do not agree to this study and those who are not appropriate for this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Nagano
Organization	Kobe University School of medicine
Division name	Division of Respiratory Medicine
Zip code	650-0017
Address	7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL	078-382-5660
Email	tnagano@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Nagano
Organization	Kobe University Hospital
Division name	Division of Respiratory Medicine
Zip code	650-0017
Address	7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL	078-382-5660
Homepage URL
Email	tnagano@med.kobe-u.ac.jp

Sponsor
Institute	Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National institutes of biomedical innovation, health and nutrition
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital
Address	7-5-2 Kusunoki-cho Chuo-ku Kobe City
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

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 06 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	Open public recruiting
Date of protocol fixation	2020 Year 05 Month 26 Day
Date of IRB	2020 Year 05 Month 26 Day
Anticipated trial start date	2020 Year 05 Month 27 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2020 Year 05 Month 27 Day
Last modified on	2020 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045412

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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