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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016464
Receipt No. R000019123
Scientific Title Development of Digital PCR Diagnostic Assay for Infectious diseases.
Date of disclosure of the study information 2015/02/06
Last modified on 2019/08/14

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Basic information
Public title Development of Digital PCR Diagnostic Assay for Infectious diseases.
Acronym Development of Digital PCR Diagnostic Assay for Infectious diseases.
Scientific Title Development of Digital PCR Diagnostic Assay for Infectious diseases.
Scientific Title:Acronym Development of Digital PCR Diagnostic Assay for Infectious diseases.
Region
Japan

Condition
Condition Mycobacterium tubeculosis infection
Pneumocystis pneumoniae
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating of the Digital PCR assay targeting the pathogenic microorganism specific genes using purified DNA from samples other than respiratory secretions as a diagnostic assay.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Consistency with existing diagnostic methods
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
Interventions/Control_1 Conducting Digital PCR assay targeting the pathogenic microorganism specific genes using purified DNA from blood or other body fluid samples.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals with active TB infection who are planned to start on anti-tuberculosis chemotherapy and have capability of informed consent.

Individuals with or suspected with pneumocystis pneumonia who have capability of informed consent.
Key exclusion criteria Individuals without capability of informed consent.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Yamamoto
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Respirology
Zip code
Address 3-9 Fukuura,Kanazawa-ku, Yokohama, 236-0004, Japan
TEL 045-787-2630
Email masakiy@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Yamamoto
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Respirology
Zip code
Address 3-9 Fukuura,Kanazawa-ku, Yokohama, 236-0004, Japan
TEL 045-787-2630
Homepage URL
Email masakiy@yokohama-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Yokohama City University, Department of Respirology
Institute
Department

Funding Source
Organization Graduate School of Medicine, Yokohama City University, Department of Respirology
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
Address
Tel
Email

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
2015 Year 02 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results M. tubeculosis specific DNA sequences could be detected in cell-free DNA from smear-positive pulmonary TB patients plasma samples.
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
2015 Year 01 Month 15 Day
Date of IRB
2015 Year 01 Month 09 Day
Anticipated trial start date
2015 Year 01 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 06 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019123

Research Plan
Registered date File name
2018/02/08 Digital PCR 計画書 2018.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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