UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study evaluating clinical significance of serial quantification of PCT in respiratory diseases
Title of the study (Brief title)	PCT in CAP
Region	Japan

Condition
Condition	Respiratory diseases
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify clinical significances of serial quantification of PCT in respiratory diseases.
Basic objectives2	Others
Basic objectives -Others	To evaluate an usefulness of PCT as a prognositic biomarker of respiratoty diseases
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	30 day mortality
Key secondary outcomes	Severity, initial treatment failure, causative pathogen of infectious diseases

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with respiratory diseases Healthy individuals as control
Key exclusion criteria	Patients without lung diseases
Target sample size	500

Research contact person
Name of lead principal investigator	Masato Watanabe
Organization	Fukujuji Hopital
Division name	Respiratory Medicine Division
Address	3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL	042-491-4111
Email	masatowa1973@gmail.com

Public contact
Name of contact person	Masato Watanabe
Organization	Fukujuji Hopital
Division name	Respiratory Medicine Division
Address	3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL	042-491-4111
Homepage URL
Email	masatowa1973@gmail.com

Sponsor
Institute	Respiratory Medicine Division, Fukujuji Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Wako Pure Chemical Industries, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kyorin University
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	複十字病院、杏林大学

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 12 Month 17 Day
Anticipated trial start date	2013 Year 12 Month 17 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry	2020 Year 01 Month 01 Day
Date trial data considered complete	2020 Year 01 Month 01 Day
Date analysis concluded	2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Randam sampling

Management information
Registered date	2013 Year 12 Month 29 Day
Last modified on	2016 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000014868