UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012727 |
|---|---|
| Receipt number | R000014868 |
| Scientific Title | Prospective observational study evaluating clinical significance of serial quantification of PCT in respiratory diseases |
| Date of disclosure of the study information | 2013/12/29 |
| Last modified on | 2016/04/04 16:40:39 |
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Basic information
Public title
Prospective observational study evaluating clinical significance of serial quantification of PCT in respiratory diseases
Acronym
PCT in CAP
Scientific Title
Prospective observational study evaluating clinical significance of serial quantification of PCT in respiratory diseases
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Masato Watanabe |
Organization
Fukujuji Hopital
Division name
Respiratory Medicine Division
Zip code
Address
3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL
042-491-4111
masatowa1973@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Watanabe |
Organization
Fukujuji Hopital
Division name
Respiratory Medicine Division
Zip code
Address
3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL
042-491-4111
Homepage URL
masatowa1973@gmail.com
Sponsor or person
Institute
Respiratory Medicine Division, Fukujuji Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014868
