UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014045
Receipt number R000016353
Scientific Title Evaluation of elastic fibers by urinary desimosine and isodesmosine in interstitial pneumonias
Date of disclosure of the study information 2014/05/22
Last modified on 2016/11/22 13:40:19

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Basic information

Public title

Evaluation of elastic fibers by urinary desimosine and isodesmosine in interstitial pneumonias

Acronym

Urinary desmosine in interstitial pneumonias

Scientific Title

Evaluation of elastic fibers by urinary desimosine and isodesmosine in interstitial pneumonias

Scientific Title:Acronym

Urinary desmosine in interstitial pneumonias

Region

Japan


Condition

Condition

Interstitial pneumonias

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate elastic fibers by urinary desmosine and isodesmosine in interstitial pneumonias, and to confirm the correlation between urinary desmosines and type of interstitial pneumonia and its prognosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the correlation between urinary desimosine and the clinical parameters such as type of interstitial pneumonia, extent of lesion in chest CT, pulmonary function test, laboratory findings, the pathological findings, response to treatment, and prognosis.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with interstitial pneumonia

Key exclusion criteria

none

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takafumi Suda

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code


Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

TEL

053-435-2263

Email

suda@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiyuki Oyama

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code


Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan

TEL

053-435-2263

Homepage URL


Email

y-oyama@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

浜松医科大学病院、聖隷三方原病院、磐田市立総合病院、浜松労災病院、福岡大学病院、神奈川循環器呼吸器病センター、金沢大学病院、徳島大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 22 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

2012 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 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

We have closed registration, summarized the results, and submitted a paper.


Management information

Registered date

2014 Year 05 Month 22 Day

Last modified on

2016 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name