UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on the diagnosis and treatment of respiratory diseases
Title of the study (Brief title)	Observational study of respiratory diseases
Region	Japan

Condition
Condition	Thoracic tumor Chronic obstructive pulmonary disease Bronchial asthma Interstitial pneumonia Chronic respiratory infectious diseases
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Regarding various respiratory diseases while undergoing medical examination, to set criteria for examination and examination necessary for gathering information on disease condition and medical treatment contents, and grasp changes in medical condition of various respiratory diseases and changes over time in medical treatment contents.
Basic objectives2	Others
Basic objectives -Others	Prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptoms, Physical examination, X-ray, CT scan, Pulmonary function tests, cardiac function, blood test, EGFR/ALK, pathology, etc.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients in our hospital
Key exclusion criteria	Patients who refuse the inclusion of this study
Target sample size	500

Research contact person
Name of lead principal investigator	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Email	drtake1118@gmail.com

Public contact
Name of contact person	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Homepage URL
Email	drtake1118@gmail.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Center
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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 05 Day
Anticipated trial start date	2017 Year 02 Month 14 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	Study design: cohort study Study period: February 15, 2017 to December 31, 2021

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030022