UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016464 |
|---|---|
| Receipt number | 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 19:58:41 |
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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
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
masakiy@yokohama-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University, Department of Respirology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019123
