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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name