UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032926
Receipt number R000037537
Scientific Title Analysis for autoimmune components and the disease activity of interstitial pneumonia patients
Date of disclosure of the study information 2018/06/08
Last modified on 2023/06/13 06:32:07

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Basic information

Public title

Analysis for autoimmune components and the disease activity of interstitial pneumonia patients

Acronym

Interstitial pneumonia associated with autoimmune

Scientific Title

Analysis for autoimmune components and the disease activity of interstitial pneumonia patients

Scientific Title:Acronym

Interstitial pneumonia associated with autoimmune

Region

Japan


Condition

Condition

patients with interstitial pneumonia

Classification by specialty

Medicine in general Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

positive ratio of autoantibodies

Basic objectives2

Others

Basic objectives -Others

Positive ratio of autoantibodies and the survival rate of the patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

positive ratio of autoantibodies

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

20 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with interstititial shadow
COPD
Asthma

Key exclusion criteria

<20 years old

Target sample size

900


Research contact person

Name of lead principal investigator

1st name Yoshiki
Middle name
Last name Yoshiki

Organization

Dokkyo Medical University School of Medicine

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code

321-0293

Address

880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan

TEL

0282861111

Email

ishiiysk@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Yasuo
Middle name
Last name Shimizu

Organization

Dokkyo Medical University School of Medicine

Division name

Department of Pulmonary Medicine and Clinical Immunology

Zip code

321-0293

Address

880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan

TEL

0282861111

Homepage URL


Email

yasuo-s@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Dokkyo University Hospital

Address

880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi

Tel

0282-87-2151

Email

r-kenkyu@dokkyomed.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



Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 08 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

Open public recruiting

Date of protocol fixation

2018 Year 04 Month 18 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 06 Month 08 Day

Last modified on

2023 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name