UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045715
Receipt number R000052187
Scientific Title Diagnostic accuracy of IGRA in HIV patients
Date of disclosure of the study information 2021/10/11
Last modified on 2023/07/12 17:22:04

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Basic information

Public title

Diagnostic accuracy of IGRA in HIV patients

Acronym

Diagnostic accuracy of IGRA in HIV patients

Scientific Title

Diagnostic accuracy of IGRA in HIV patients

Scientific Title:Acronym

Diagnostic accuracy of IGRA in HIV patients

Region

Japan Asia(except Japan)


Condition

Condition

TB

Classification by specialty

Medicine in general Infectious disease Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Test accuracy of IGRA in HIV patients

Basic objectives2

Others

Basic objectives -Others

TB patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity

Key secondary outcomes

Specificity


Base

Study type

Others,meta-analysis etc


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with TB infection suspect

Key exclusion criteria

Patients without information on sensitivity or specificity

Target sample size



Research contact person

Name of lead principal investigator

1st name Hao
Middle name
Last name Chen

Organization

Teikyo university hospital

Division name

Internal medicine

Zip code

173-8606

Address

Teikyo University Hospital, 2-11-1 Kaga, Itahashi, Tokyo

TEL

03-3964-1211

Email

chinsmd@gmail.com


Public contact

Name of contact person

1st name Hao
Middle name
Last name Chen

Organization

Teikyo University Hospital

Division name

Internal medicine

Zip code

173-8606

Address

Teikyo University Hospital, 2-11-1 Kaga, Itahashi, Tokyo

TEL

03-3964-1211

Homepage URL


Email

chinsmd@gmail.com


Sponsor or person

Institute

Teikyo University Hospital

Institute

Department

Personal name



Funding Source

Organization

Teikyo University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

not available

Address

not available

Tel

not available

Email

not available


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

2021 Year 10 Month 11 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

Completed

Date of protocol fixation

2021 Year 10 Month 10 Day

Date of IRB

2021 Year 10 Month 11 Day

Anticipated trial start date

2021 Year 10 Month 11 Day

Last follow-up date

2021 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1 Department of Internal medicine, Teikyo University Graduate School of Medicine, Tokyo, Japan
2 Department of Respiratory, Kobe City Medical Center General Hospital, Kobe, Japan
3 Department of Respiratory, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan
4 Department of Respiratory, Niigata Prefectural Shibata Hospital, Niigata, Japan
5 Department of Emergency Medicine, Kawasaki Medical School Hospital, Japan
6 Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama,


Management information

Registered date

2021 Year 10 Month 11 Day

Last modified on

2023 Year 07 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052187