UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer
Title of the study (Brief title)	Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to clarify the risk factors associated with respiratory infectious complications after diagnostic bronchoscopy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to elucidate the risf factors of respiratory infectious complications
Key secondary outcomes	frequency of respiratory infectious complications

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	patients who will receive the bronchoscopy for the diagnosis of lung cancer
Key exclusion criteria	patients who do not accept to be included in the observational study patients for whom primary physicians do not think suitable for the clinical study
Target sample size	400

Research contact person
Name of lead principal investigator	Shiro Imokawa
Organization	Iwata City Hospital
Division name	Department of Respiratory Medicine
Address	512-3 Okubo, Iwata, Shizuoka, 438-8550, Japan
TEL	0538-38-5000
Email	fmrcw925@ybb.ne.jp

Public contact
Name of contact person	Shiro Imokawa
Organization	Iwata City Hospital
Division name	Department of Respiratory Medicine
Address	512-3, Ookubo, Iwata, Shizuoka, 438-8550, Japan
TEL	0538-38-5000
Homepage URL
Email	fmrcw925@ybb.ne.jp

Sponsor
Institute	Iwata City Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	磐田市立総合病院（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	frequency of respiratory infectious complications within 14 days after diagnostic bronchoscopy for the diagnosis of lung cancer and check the following:height, weight, BMI, TP, Alb, TG, TC, BS, HbA1c, liver function, renal function, arterial blood gas analysis, associateddiseases, the size, characteristic findings and location of the tumor,

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2017 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026222