Unique ID issued by UMIN | UMIN000036829 |
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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 |
Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of advanced cell-mediated immune deficiency patients by HIV infection
Abbott RealTime CMV Domestic Clinical Performance Trial
Evaluation of the utility of Abbott RealTime CMV in monitoring CMV infection of advanced cell-mediated immune deficiency patients by HIV infection
Abbott RealTime CMV Domestic Clinical Performance Trial
Japan |
Human immunodeficiency virus infection
Medicine in general | Infectious disease |
Others
NO
Investigate the clinical utility of Abbott RealTime CMV in monitoring CMV infection of HIV patients
Bio-equivalence
Sensitivity and specificity in the detection of CMV infection using Abbott RealTime CMV (when antigenemia is a standard method)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
10
1st name | Masayuki |
Middle name | |
Last name | Murata |
Kyushu University Hospital
Department of General Internal Medicine
812-8582
3-1-1 Maidashi Higashi-ku, Fukuoka
092-642-5909
mmurata@gim.med.kyushu-u.ac.jp
1st name | Yutaka |
Middle name | |
Last name | Seki |
Abbott Japan Co., Ltd.
Molecular Division
108-6305
3-5-27 Mita, Minato-ku, Tokyo
03-4555-1099
yutaka.seki@abbott.com
Abbott Japan Co., Ltd.
Abbott Japan Co., Ltd.
Profit organization
Kyushu University Hospital, Institutional Review Board
3-1-1, Maidashi, Higashi-ku, Fukuoka
092-642-5774
bysirboffice@jimu.kyushu-u.ac.jp
NO
2019 | Year | 05 | Month | 24 | Day |
Unpublished
7
Completed
2017 | Year | 07 | Month | 21 | Day |
2017 | Year | 08 | Month | 28 | Day |
2017 | Year | 11 | Month | 21 | Day |
2018 | Year | 10 | Month | 09 | Day |
Study design: A prospective non-interventional observational study
2019 | Year | 05 | Month | 23 | Day |
2019 | Year | 05 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041934
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