UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038981
Receipt number R000044360
Scientific Title How comprehensive is the Cochrane Central Register of Controlled Trials for identifying clinical trial registration?: a diagnostic study
Date of disclosure of the study information 2019/12/26
Last modified on 2020/08/11 16:50:12

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Basic information

Public title

How comprehensive is the Cochrane Central Register of Controlled Trials for identifying clinical trial registration?: a diagnostic study

Acronym

Searching the Cochrane Central Register of Controlled Trials for identifying clinical trial registration

Scientific Title

How comprehensive is the Cochrane Central Register of Controlled Trials for identifying clinical trial registration?: a diagnostic study

Scientific Title:Acronym

Searching the Cochrane Central Register of Controlled Trials for identifying clinical trial registration

Region

Japan Asia(except Japan) North America
South America Australia Europe
Africa


Condition

Condition

Records about ongoing or unpublished studies registered on the International Clinical Trials Registry Platform (ICTRP) or ClinicalTrials.gov (CT.gov) in the latest interventional Cochrane Database of Systematic Reviews (CDSRs)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the sensitivity and number needed to read (NNR), with its 95 % confidence interval, of Cochrane Central Register of Controlled Trials (CENTRAL) search to identify ongoing or unpublished studies.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the sensitivity, with its 95 % confidence interval, of CENTRAL search

Key secondary outcomes

NNR, with its 95 % confidence interval, of CENTRAL search


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

Inclusion criteria about CDSRs: CDSRs during the last six months.
Inclusion criteria about ongoing or unpublished studies for reference standard: records about ongoing or unpublished studies registered on the ICTRP or CT.gov in the included interventional CDSRs

Key exclusion criteria

Exclusion criteria about CDSRs: CDSRs that used Cochrane Review Group Specialized Registers or CDSRs that did not use CENTRAL, ICTRP, or CT.gov. CDSRs that searched non-randomized trials, the trials other than randomized controlled trials (RCTs) or quasi-randomized controlled trials (quasi-RCTs).

Target sample size

0


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Banno

Organization

Seichiryo Hospital

Division name

Department of Psychiatry

Zip code

4660064

Address

4-16-27, Tsurumai, Showa-ku, Nagoya City, Aichi Prefecture, 466-0064 Japan

TEL

+81-52-741-1231

Email

delerium.rurutia2018@gmail.com


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Banno

Organization

Seichiryo Hospital

Division name

Department of Psychiatry

Zip code

4660064

Address

4-16-27, Tsurumai, Showa-ku, Nagoya City, Aichi Prefecture, 466-0064 Japan

TEL

+81-52-741-1231

Homepage URL


Email

delerium.rurutia2018@gmail.com


Sponsor or person

Institute

Department of Psychiatry, Seichiryo Hospital

Institute

Department

Personal name



Funding Source

Organization

1. Systematic Review Workshop Peer Support Group (SRWS-PSG)
2. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center
3. Nagoya University Academy of Psychiatry

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

Seichiryo Hospital

Address

4-16-27, Tsurumai, Showa-ku, Nagoya City, Aichi Prefecture, 466-0064 Japan

Tel

+81-52-741-1231

Email

delerium.rurutia2018@gmail.com


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

2019 Year 12 Month 26 Day


Related information

URL releasing protocol

https://medrxiv.org/cgi/content/short/2019.12.26.19014274v1

Publication of results

Published


Result

URL related to results and publications

https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-020-01083-y

Number of participants that the trial has enrolled

247

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

2019 Year 12 Month 27 Day

Date of IRB

2019 Year 12 Month 09 Day

Anticipated trial start date

2020 Year 01 Month 02 Day

Last follow-up date

2020 Year 04 Month 12 Day

Date of closure to data entry

2020 Year 04 Month 15 Day

Date trial data considered complete

2020 Year 04 Month 15 Day

Date analysis concluded

2020 Year 04 Month 15 Day


Other

Other related information

Sensitivity, and its 95 % confidence interval, of CENTRAL search


Management information

Registered date

2019 Year 12 Month 25 Day

Last modified on

2020 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044360


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name