UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036024 |
|---|---|
| Receipt number | R000040477 |
| Scientific Title | Evaluation of digital PCR in patients with pulmonary tuberculosis and mycobacterium avium-complex infection. |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2021/03/09 00:07:57 |
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Basic information
Public title
Evaluation of digital PCR in patients with pulmonary tuberculosis and mycobacterium avium-complex infection.
Acronym
Evaluation of digital PCR in mycobacterial patients.
Scientific Title
Evaluation of digital PCR in patients with pulmonary tuberculosis and mycobacterium avium-complex infection.
Scientific Title:Acronym
Evaluation of digital PCR in mycobacterial patients.
Region
| Japan |
Condition
Condition
Pulmonary tuberculosis
Mycobacterium avium-complex infection
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We evaluated the efficacy of digital PCR for collecting specimens ( sputum, saliva, blood, urine, BALF ) in the diagnosis of pulmonary tuberculosis and mycobacterium avium-complex infection.
Basic objectives2
Others
Basic objectives -Others
We evaluated the blood test ( serum albumin, MAC antibody, erythrocyte sedimentation rate ), comorbidity, and disease activity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Digital PCR ( sputum, saliva, blood, urine, BALF ).
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Specimens ( sputum, saliva, blood, urine, BALF ) sampling.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who suspected with pulmonary tuberculosis and mycobacterium avium-complex infection. Individuals with capability of informed consent.
Key exclusion criteria
Individuals without capability of informed .
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Nishii |
Organization
Matsusaka municipal hospital respiratory center
Division name
Pulmonologist
Zip code
515-8544
Address
Mie prefecture Matsusaka city Tonomachi 1550th
TEL
0598-23-1515
mchnishii@city-hosp.matsusaka.mie.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Nishii |
Organization
Matsusaka municipal hospital respiratory center
Division name
Pulmonologist
Zip code
515-8544
Address
Mie prefecture Matsusaka city Tonomachi 1550th
TEL
0598-23-1515
Homepage URL
mchnishii@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka municipal hospital respiratory center
Institute
Department
Personal name
Funding Source
Organization
Matsusaka municipal hospital respiratory center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka municipal hospital respiratory center
Address
Mie prefecture Matsusaka city Tonomachi 1550th
Tel
0598-23-1515
mchnishii@city-hosp.matsusaka.mie.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
松阪市民病 院呼吸器センター（三重県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040477
