UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040110
Receipt number R000045735
Scientific Title Cloud migration of clinical research data
Date of disclosure of the study information 2020/04/10
Last modified on 2020/06/07 16:31:41

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Basic information

Public title

Cloud migration of clinical research data

Acronym

Cloud migration of clinical research data

Scientific Title

Cloud migration of clinical research data

Scientific Title:Acronym

Cloud migration of clinical research data

Region

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


Condition

Condition

not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We are required to process a large amount of information for clinical and basic science research. However, most researchers use spreadsheet and/or notebooks. We have recently developed a database that integrates such information. The database runs on a single off-line computer to protect information including patient identification data. In this study, we will upload the database to a cloud service (Aim 1), determine if the program can be shared among collaborators (Aim 2), explore if the database automatically identifies patients who will be candidate of clinical trials (Aim 3), and clarify if the database is superior to conventional methods for selecting such candidates.

Basic objectives2

Others

Basic objectives -Others

See "Narrative objectives1"

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We will clarify whether the function of this system contributes to more efficient and accurate clinical research.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All patients at the study site

Key exclusion criteria

Patients who do not consent to the publication of research information

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Koshiro
Middle name
Last name Nishimoto

Organization

Saitama Medical University International Medical Center

Division name

Department of UroOncology

Zip code

350-1298

Address

1397-1 Yamane, Hidaka, Saitama, Japan

TEL

042-984-4111

Email

kn7961@5931.saitama-med.ac.jp


Public contact

Name of contact person

1st name Koshiro
Middle name
Last name Nishimoto

Organization

Saitama Medical University International Medical Center

Division name

Department of UroOncology

Zip code

350-1298

Address

1397-1 Yamane, Hidaka, Saitama, Japan

TEL

042-984-4111

Homepage URL


Email

kn7961@5931.saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical University International Medical Center Clinical Research Properness Promotion Center

Address

1397-1 Yamane, Hidaka, Saitama, Japan

Tel

042-984-4523

Email

chikens@saitama-med.ac.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

2020 Year 04 Month 10 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

Enrolling by invitation

Date of protocol fixation

2020 Year 02 Month 19 Day

Date of IRB

2020 Year 03 Month 04 Day

Anticipated trial start date

2020 Year 03 Month 04 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

not applicable


Management information

Registered date

2020 Year 04 Month 08 Day

Last modified on

2020 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045735


Research Plan
Registered date File name
2020/06/07 実施計画書_ver2_2020-4-6.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name