UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040726 |
|---|---|
| Receipt number | R000046491 |
| Scientific Title | Prognostic values of histopathologic findings in patients with acute respiratory distress syndrome; A systematic review and |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2021/03/02 13:26:35 |
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Basic information
Public title
Prognostic values of histopathologic findings in patients with acute respiratory distress syndrome; A systematic review and
Acronym
Prognostic values of histopathologic findings in patients with acute respiratory distress syndrome; A systematic review and
Scientific Title
Prognostic values of histopathologic findings in patients with acute respiratory distress syndrome; A systematic review and
Scientific Title:Acronym
Prognostic values of histopathologic findings in patients with acute respiratory distress syndrome; A systematic review and
Region
| Japan |
Condition
Condition
Acute respiratory distress syndrome
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of our study is to perform systematic review and meta-analysis to identify the prognostic values of histopathologic findings in patients with ARDS
Basic objectives2
Others
Basic objectives -Others
systematic review and meta-analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, sensitivity and receiver operating characteristics
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will include all reports on the prognostic values of histopathologic findings in patients with ARDS. We will include the studies designed as prospective or retrospective observational (cohort or cross-sectional) studies, or secondary analysis of randomized controlled trials.
Key exclusion criteria
We will exclude diagnostic case control studies. We will exclude case studies that did not provide data about prognostic values
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Graduate school of medicine, Kyoto University
Division name
The department of pharmacoepidemiology
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539469
hashimoto.hiroyuki.36w@st.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Graduate school of medicine, Kyoto University
Division name
The department of pharmacoepidemiology
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL
0757539469
Homepage URL
hashimoto.hiroyuki.36w@st.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate school of medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medicine, Kyoto University
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
None
Address
None
Tel
None
None
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
| 2020 | Year | 06 | Month | 20 | 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
| 2020 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 03 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 03 | Day |
Other
Other related information
The need for ethical approval and consent was waived for this systematic review.
A fictitious date was entered above because clinical trial registration cannot be completed without entering the date of ethical review.
Participants
The target participants are patients with Acute respiratory distress syndrome.
Target condition
Target condition is mortality or other adverse events
Setting
Any type of settings are included.
Index test
The index test is histopathologic findings such as diffuse alveolar damages.
Reference standard is death which is reported in manuscripts
Management information
Registered date
| 2020 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046491
