UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036024
Receipt No. 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 2019/03/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mchnishii@city-hosp.matsusaka.mie.jp

Sponsor
Institute Matsusaka municipal hospital respiratory center
Institute
Department

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
Email 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
2020 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
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.