UMIN-CTR Clinical Trial

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
Email	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
Email	hashimoto.hiroyuki.36w@st.kyoto-u.ac.jp

Sponsor
Institute	Graduate school of medicine, Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046491