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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035013
Receipt No. R000039922
Scientific Title Role of intestinal and salivery microbiota in pulmonary diseases
Date of disclosure of the study information 2018/11/26
Last modified on 2018/11/26

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Basic information
Public title Role of intestinal and salivery microbiota in pulmonary diseases
Acronym Role of intestinal and salivery microbiota in pulmonary diseases
Scientific Title Role of intestinal and salivery microbiota in pulmonary diseases
Scientific Title:Acronym Role of intestinal and salivery microbiota in pulmonary diseases
Region
Japan

Condition
Condition The patients with pulmonary diseases including lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the roles of intestinal and salivery microbiota in patients with pulmonary diseases including lung cancer
Basic objectives2 Others
Basic objectives -Others To evaluate the roles of intestinal and salivery microbiota in patients with pulmonary diseases including lung cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comprehensive analyses of intestinal and salivery microbiota in the patients with pulmonary diseases including lung cancer
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 some treatments for pulmonary diseases.
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 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nojiri
Organization Higashiosaka City Medical Center
Division name General Thoracic Surgery
Zip code
Address 3-4-5, Nishi-iwata Higashiosaka-City
TEL 0667815101
Email honnnori2003@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nojiri
Organization Higashiosaka City Medical Center
Division name General Thoracic Surgery
Zip code
Address 3-4-5, Nishi-iwata Higashiosaka-City
TEL 0667815101
Homepage URL
Email honnnori2003@yahoo.co.jp

Sponsor
Institute Higashiosaka City Medical Center
Institute
Department

Funding Source
Organization None
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 市立東大阪医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 11 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 09 Month 30 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039922

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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