UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020502 |
|---|---|
| Receipt number | R000023612 |
| Scientific Title | Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases. |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2016/04/26 14:44:44 |
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Basic information
Public title
Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases.
Acronym
Biomarkers in healthy subjects.
Scientific Title
Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases.
Scientific Title:Acronym
Biomarkers in healthy subjects.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Medicine in general | Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare serum/plasma biomarker levels of healthy subjects to lung disease patients.
Basic objectives2
Others
Basic objectives -Others
Explorative research for biomarkers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Biomarker levels
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Key exclusion criteria
Subjects who have no consent ability.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watanabe |
Organization
Kyorin University
Division name
Department of respiratory medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611 Japan
TEL
0422-47-5511
masato@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Watanabe |
Organization
Kyorin University
Division name
epartment of respiratory medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611 Japan
TEL
0422-47-5511
Homepage URL
masato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kosei Hospital, Nomura Hospital, Morimoto Hospital, Jiundoh Hospital, or Kurai Naika Clinic, who meet to our inclusion criteria, and who provide us a written informed consent.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An observational study of healthy volunteers (case control study comparing to patients with respiratory disease).
We will obtain serum/plasma sample from donors (without respiratory diseases) who visit Kyorin University Hospital, Kousei Hospital, Nomura Hospital, Morimoto Hospital, Jiundoh Hospital, or Kurai Naika Clinic, Yasaka Kinen Hospital, who meet to our inclusion criteria, and who provide us a written informed consent.
We will measure serum/plasma levels of biomarkers for lung diseases (i.e. IL-8, IL-6, sST2, LL-37, IL-33, carnitine, H2O2, and others).
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2016 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023612
