UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032888
Receipt number R000037494
Scientific Title Investigation of biomarkers for diagnosis and treatment of pulmonary hypertension.
Date of disclosure of the study information 2018/07/01
Last modified on 2020/06/08 09:53:31

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Basic information

Public title

Investigation of biomarkers for diagnosis and treatment of pulmonary hypertension.

Acronym

Biomarkers for pulmonary hypertension.

Scientific Title

Investigation of biomarkers for diagnosis and treatment of pulmonary hypertension.

Scientific Title:Acronym

Biomarkers for pulmonary hypertension.

Region

Japan


Condition

Condition

Pulmonary hypertension

Classification by specialty

Cardiology Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objectives of this study is to establish the biomarkers for early daiagnosis and useful treatment of pulmonary hypertension.

Basic objectives2

Others

Basic objectives -Others

Verification of usefulness of serum periostin and blood - derived exosomes as a biomarker in pulmonary hypertension.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

level of serum periostin.
Profile of microRNA and protein in exosome from blood sample.

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient who is diagnosed as pulmonary hypertension including from group 1 to 5 in international classification.

Key exclusion criteria

Patient who has not undergone right heart catheterization and has not reached definite diagnosis of pulmonary hypertension.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tetsutaro
Middle name
Last name Nagaoka

Organization

Juntendo University

Division name

Division of respiratory medicine

Zip code

113-8431

Address

Nerima-ku

TEL

0358021063

Email

jnagaoka@juntendo.ac.jp


Public contact

Name of contact person

1st name Tetsutaro
Middle name
Last name Nagaoka

Organization

Juntendo University

Division name

Division of respiratory medicine

Zip code

113-8431

Address

3-1-3 Hongo Bunkyo-ku, Tokyo, Japan

TEL

03-5802-1063

Homepage URL


Email

jnagaoka@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo university

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

Juntendo University Hospital

Address

3-1-3 Hongo

Tel

+81358021063

Email

jnagaoka@juntendo.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 07 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

Open public recruiting

Date of protocol fixation

2018 Year 05 Month 31 Day

Date of IRB

2018 Year 05 Month 31 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We verify the correlation between severity of pulmonary hypertension and biomarkers in each group.


Management information

Registered date

2018 Year 06 Month 06 Day

Last modified on

2020 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037494


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name