UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005481 |
|---|---|
| Receipt number | R000006494 |
| Scientific Title | The role of selenium and selenoprotien-P in pulmonary diseases. |
| Date of disclosure of the study information | 2011/04/21 |
| Last modified on | 2020/10/28 09:44:53 |
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Basic information
Public title
The role of selenium and selenoprotien-P in pulmonary diseases.
Acronym
The role of selenium and selenoprotien-P in pulmonary diseases.
Scientific Title
The role of selenium and selenoprotien-P in pulmonary diseases.
Scientific Title:Acronym
The role of selenium and selenoprotien-P in pulmonary diseases.
Region
| Japan |
Condition
Condition
Pulmonary diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the role of selenium and selenoprotein-P in pulmonary diseases.
Basic objectives2
Others
Basic objectives -Others
To evaluate the usefulness of selenium and selenoprotein-P concentrations in serum as a biomarker.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between selenium and selenoprotein-P in serum and severety and prognosis of pulmonary diseases.
Key secondary outcomes
The relationship between selenium and selenoprotein-P in serum and clinical parameters of pulmonary 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as having pulmonary diseases such as interstitial pneumonia, sarcoidosis, acute pneumonia, chronic obstructive pulmonary disease (COPD), eosinophilic pneumonia and lung cancer in the Department of Pulmonary Medicine, Fukushima Medical University Hospital and normal volunteers. They received serum sampling and agreed to be involved in this clinical study.
Key exclusion criteria
Patients with pulmonary diseases without serum sampling.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Munakata |
Organization
School of Medicine, Fukushima Medical University
Division name
Department of Pulmonary Medicine
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL
024-547-1360
pulmo@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Tanino |
Organization
School of Medicine, Fukushima Medical University
Division name
Department of Pulmonary Medicine
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL
024-547-1360
Homepage URL
http://www.fmu.ac.jp
pulmo@fmu.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
q Hikarigaoka, Fukushima, 9601295, JAPAN
Tel
0245471360
pulmo@fmu.ac.jp
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
福島県立医科大学病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinical significance of selenium and selenoprotein-P has not been clarified. Therefore, we will perfoem the prospective observational study to evaluate the relationship between selenium and selenoprotein-P in serum from patients with pulmonary diseases and clinical parameters and prognosis. For the subjects who had been already underwent the serum sampling and agreed to be involved in this clinical study will be included and analyzed restrospectively.
Management information
Registered date
| 2011 | Year | 04 | Month | 21 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006494
