UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039135
Receipt number R000044636
Scientific Title DevelopmeNT of diAgnostic method for Infective Endocarditis using comprehensive genomics approach
Date of disclosure of the study information 2020/01/20
Last modified on 2020/01/14 13:06:33

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Basic information

Public title

DevelopmeNT of diAgnostic method for Infective Endocarditis using comprehensive genomics approach

Acronym

DENTA-IE study

Scientific Title

DevelopmeNT of diAgnostic method for Infective Endocarditis using comprehensive genomics approach

Scientific Title:Acronym

DENTA-IE study

Region

Japan


Condition

Condition

infectious endocarditis

Classification by specialty

Medicine in general Dental medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Evaluating the effect of oral bacteria on infectious endocarditis by using the principles of genomics

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quantitative evaluation of the ratio of each bacterial species to the total bacterial count and the oral bacterial count, which were suspected 16srRNA analysis, using real-time PCR and IgG serum antibody titers in a patient with f infectious endocarditis

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients with infective endocarditis in Teikyo University Hospital

Key exclusion criteria

Patients from whom we cannot obtain the consent of this study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Akihisa
Middle name
Last name Kataoka

Organization

Teikyo University

Division name

Department of Medicine

Zip code

173- 8606

Address

2-11-1 Kaga, Itabashi-ku, Tokyo 173- 8606, Japan

TEL

+81-3-3964-1211

Email

kataoaki@sd5.so-net.ne.jp


Public contact

Name of contact person

1st name Akihisa
Middle name
Last name Kataoka

Organization

Teikyo University

Division name

Department of Medicine

Zip code

173- 8606

Address

2-11-1 Kaga, Itabashi-ku, Tokyo 173- 8606, Japan

TEL

+81-3-3964-1211

Homepage URL


Email

kataoaki@sd5.so-net.ne.jp


Sponsor or person

Institute

Teikyo University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental 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

Teikyo University Research Ethics Committee

Address

2-11-1 Kaga, Itabashi-ku, Tokyo 173- 8606, Japan

Tel

03-3964-7256

Email

turb-office@teikyo-u.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

2020 Year 01 Month 20 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 10 Month 22 Day

Date of IRB

2019 Year 04 Month 03 Day

Anticipated trial start date

2019 Year 04 Month 03 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: observation study

Research period: Apr 3, 2019 to Mar 31, 2023

Objective: Inpatients with infective endocarditis in Teikyo University Hospital

Primary outcomes: Quantitative evaluation of the ratio of each bacterial species to the total bacterial count and the oral bacterial count, which were suspected 16srRNA analysis, using real-time PCR and IgG serum antibody titers in a patient with f infectious endocarditis


Management information

Registered date

2020 Year 01 Month 12 Day

Last modified on

2020 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name