UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050768 |
|---|---|
| Receipt number | R000057850 |
| Scientific Title | Would you recommend multiple repeat sputum nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis? |
| Date of disclosure of the study information | 2023/04/05 |
| Last modified on | 2023/04/05 11:12:33 |
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Basic information
Public title
Would you recommend multiple repeat sputum nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis?
Acronym
Would you recommend multiple repeat sputum nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis?
Scientific Title
Would you recommend multiple repeat sputum nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis?
Scientific Title:Acronym
Would you recommend multiple repeat sputum nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis?
Region
| Japan |
Condition
Condition
pulmonary tuberculosis
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Would you recommend multiple repeat sputum nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, cost
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients suspected of having pulmonary tuberculosis
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | TADASHI |
| Middle name | |
| Last name | NAGATO |
Organization
JCHO tokyot yamate medical center
Division name
Infectious Diseases Medicine
Zip code
1040054
Address
5-3-1-1921 Kachidoki, Chuo-ku, Tokyo
TEL
09089118634
chocunagato@kyudai.jp
Public contact
Name of contact person
| 1st name | KEITA |
| Middle name | |
| Last name | TAKEDA |
Organization
TOKYO HOSPITAL
Division name
Respiratory Medicine
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-shi, Tokyo
TEL
042-491-2111
Homepage URL
takeita0427@gmail.com
Sponsor or person
Institute
THE JAPANESE SOCIETY FOR TUBERCULOSIS AND NONTUBERCULOUS MYCOBACTERIOSIS
Institute
Department
Personal name
Funding Source
Organization
NONE
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
THE JAPANESE SOCIETY FOR TUBERCULOSIS AND NONTUBERCULOUS MYCOBACTERIOSIS
Address
4-11-24-A101 Takanawa, Minato-ku, Tokyo
Tel
03-6721-9983
info@kekkaku.gr.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 05 | 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
1000
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
metaanalysis
Management information
Registered date
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057850
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