UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Role of intestinal and salivery microbiota in pulmonary diseases
Title of the study (Brief title)	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	Takashi Nojiri
Organization	Higashiosaka City Medical Center
Division name	General Thoracic Surgery
Address	3-4-5, Nishi-iwata Higashiosaka-City
TEL	0667815101
Email	honnnori2003@yahoo.co.jp

Public contact
Name of contact person	Takashi Nojiri
Organization	Higashiosaka City Medical Center
Division name	General Thoracic Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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