UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053533 |
|---|---|
| Receipt number | R000061095 |
| Scientific Title | Observational study examining the feasibility of generating real-world evidence for new drug applications from the clinical trials database |
| Date of disclosure of the study information | 2024/02/04 |
| Last modified on | 2024/02/04 09:56:04 |
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Basic information
Public title
Observational study examining the feasibility of generating real-world evidence for new drug applications from the clinical trials database
Acronym
REALISE study
Scientific Title
Observational study examining the feasibility of generating real-world evidence for new drug applications from the clinical trials database
Scientific Title:Acronym
REALISE study
Region
| Japan |
Condition
Condition
Unresectable solid tumors
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the data extraction methodology for external control data of rare molecular subtype
to evaluate the required quality of real-world evidence generated from real-world data as the evidence for the application for regulatory approval
Basic objectives2
Others
Basic objectives -Others
to investigate the retrospective methodologies to ensure reliability of real-world data / real-world evidence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparisons of response rate, progression-free survival, and overall survival between the data bases
comparisons of insurances of data reliability between the data bases
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Data from patients enrolled in SCRUM-Japan, SCRUM-Japan related studies, ARCAD database studies, and Flatiron health RWD study who did not refuse secondary use of information
Key exclusion criteria
Data of patients who refused to consent to the study or who explicitly refused to participate based on the content of the study published for opt-out
Data of other patients who were deemed ineligible for inclusion in the study by the investigator
Target sample size
70000
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
National Cancer Center Hospital East
Division name
Division of Drug and Diagnostic Development Promotion
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
hbando@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
National Cancer Center Hospital East
Division name
Division of Drug and Diagnostic Development Promotion
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
hbando@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Tel
04-7133-1111
ncche-irb@east.ncc.go.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
| 2024 | Year | 02 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No other information
Management information
Registered date
| 2024 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
