UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036829
Receipt number R000041934
Scientific Title Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of advanced cell-mediated immune deficiency patients by HIV infection
Date of disclosure of the study information 2019/05/24
Last modified on 2019/05/23 15:09:22

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Basic information

Public title

Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of advanced cell-mediated immune deficiency patients by HIV infection

Acronym

Abbott RealTime CMV Domestic Clinical Performance Trial

Scientific Title

Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of advanced cell-mediated immune deficiency patients by HIV infection

Scientific Title:Acronym

Abbott RealTime CMV Domestic Clinical Performance Trial

Region

Japan


Condition

Condition

Human immunodeficiency virus infection

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the clinical utility of Abbott RealTime CMV in monitoring CMV infection of HIV patients

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity and specificity in the detection of CMV infection using Abbott RealTime CMV (when antigenemia is a standard method)

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

Adults of age 20 or older
Patients diagnosed with HIV infection
Suspected to be immune deficiency
collected specimen after January 2014 (only apply for stored specimen)
Consent form obtained

Key exclusion criteria

Patients who may be unable to make the follow-up hospital visits
Blood collection tube (BCT) other than EDTA BCT were used during blood collection

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Murata

Organization

Kyushu University Hospital

Division name

Department of General Internal Medicine

Zip code

812-8582

Address

3-1-1 Maidashi Higashi-ku, Fukuoka

TEL

092-642-5909

Email

mmurata@gim.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Yutaka
Middle name
Last name Seki

Organization

Abbott Japan Co., Ltd.

Division name

Molecular Division

Zip code

108-6305

Address

3-5-27 Mita, Minato-ku, Tokyo

TEL

03-4555-1099

Homepage URL


Email

yutaka.seki@abbott.com


Sponsor or person

Institute

Abbott Japan Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Abbott Japan Co., Ltd.

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

Kyushu University Hospital, Institutional Review Board

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

Tel

092-642-5774

Email

bysirboffice@jimu.kyushu-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

2019 Year 05 Month 24 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

7

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

2017 Year 07 Month 21 Day

Date of IRB

2017 Year 08 Month 28 Day

Anticipated trial start date

2017 Year 11 Month 21 Day

Last follow-up date

2018 Year 10 Month 09 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: A prospective non-interventional observational study


Management information

Registered date

2019 Year 05 Month 23 Day

Last modified on

2019 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041934


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name