UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012178
Receipt number R000014185
Scientific Title Clinical research on application of the influenza virus detection with the nucleic acid detecting method
Date of disclosure of the study information 2014/01/01
Last modified on 2023/11/08 09:16:13

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Basic information

Public title

Clinical research on application of the influenza virus detection with the nucleic acid detecting method

Acronym

Clinical research on application of the influenza virus detection with the nucleic acid detecting method

Scientific Title

Clinical research on application of the influenza virus detection with the nucleic acid detecting method

Scientific Title:Acronym

Clinical research on application of the influenza virus detection with the nucleic acid detecting method

Region

Japan


Condition

Condition

Influenza virus infection

Classification by specialty

Medicine in general Pneumology Infectious disease
Laboratory medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Research of a nucleic acid detection diagnostic method

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Influenza infection early detection
Epidemiological data

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Swab collection

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

1. Patient with flulike symptom
2.The person by whom the informed consent document was got

Key exclusion criteria

1. Patient Who Does Not Meet Above-mentioned Selection Criterion
2. Subject Who Judged that Doctor was Unsuitable

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Hori

Organization

Juntendo University Graduate school of medicine

Division name

Department of infection control

Zip code

113-8431

Address

2-1-1 hongo bunkyo tokyo 113-8421 Japan

TEL

03-3813-3111

Email

shori@juntendo.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Yano

Organization

K.K.DNAFORM

Division name

Regulatory Affairs Dept.

Zip code

230-0045

Address

Life Science Research Center 302, 1-1-43, Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa 230-0045 Japan

TEL

045-633-4240

Homepage URL


Email

kazuhiro.yano@dnaform.jp


Sponsor or person

Institute

K.K.DNAFORM

Institute

Department

Personal name



Funding Source

Organization

K.K.DNAFORM

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

juntendo hospital IRB

Address

2-1-1 hongo bunkyo tokyo 113-8421 Japan

Tel

03-3813-3111

Email

kenkyu5858@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

2014 Year 01 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

Suspended

Date of protocol fixation

2013 Year 10 Month 11 Day

Date of IRB

2013 Year 12 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 31 Day

Last modified on

2023 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name