UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025081 |
|---|---|
| Receipt number | R000028845 |
| Scientific Title | Investigation of the prognostic factor of the sarcoidosis by using the analysis of intrapulmonary microbiome. |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2023/06/06 09:04:58 |
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Basic information
Public title
Investigation of the prognostic factor of the sarcoidosis by using the analysis of intrapulmonary microbiome.
Acronym
Prognostic factor of the sarcoidosis based on microbiome analysis.
Scientific Title
Investigation of the prognostic factor of the sarcoidosis by using the analysis of intrapulmonary microbiome.
Scientific Title:Acronym
Prognostic factor of the sarcoidosis based on microbiome analysis.
Region
| Japan |
Condition
Condition
sarcoidosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate intrapulmonary microbiome in the sarcoidosis. Also, by comparison with the clinical course of each case, we establish a prognostic factor method using a characteristic of the microbiome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intrapulmonary microbiome at diagnosis, and reduction ratio of the mediastinal hilar lymph node during three years.
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with sarcoidosis
Key exclusion criteria
The patients who cannot undergo bronchoalveolar lavage.
The patients with the serious respiratory disorder.
A pregnant woman and the patients who may be pregnant.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishimoto |
Organization
Nagasaki university hospital
Division name
Respiratory medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki city
TEL
095-819-7273
h-ishimoto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishimoto |
Organization
Nagasaki university hospital
Division name
Respiratory medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki city
TEL
095-819-7273
Homepage URL
h-ishimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Respiratory medicine, Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory medicine, Nagasaki university hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 11 | Month | 30 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
We examine association of intrapulmonary microbiome at diagnosis and the mediastinal and hilar lymph node swelling in patients with sarcoidosis.
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028845
