UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051232 |
|---|---|
| Receipt number | R000058385 |
| Scientific Title | The ARCAD database project |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2023/06/01 19:31:37 |
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Basic information
Public title
International Collaborative Research on the Construction and Utilization of an Integrated Database of Clinical Trial Information based on the ARCAD and ARCAD-Asia Databases
Acronym
The ARCAD database project
Scientific Title
The ARCAD database project
Scientific Title:Acronym
The ARCAD database project
Region
| Japan | North America | Europe |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to build a global database by jointly integrating the ARCAD Foundation (Aide et Recherche en Cancerologie Digestive) and the ARCAD-Asia and their respective databases. Furthermore, by conducting analyses using the databases, we will promote the creation of evidence and the development of treatments on a global scale.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Not applicable
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
The integrated data of patients who participated in clinical trials conducted in the past, which are already stored in ARCAD-Asia DB and ARCAD-Global DB
Key exclusion criteria
Data deemed inappropriate by the principal investigator
Target sample size
60000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
deputy Director
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
03-3542-2511
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Misumi |
Organization
National Cancer Center Hospital East
Division name
Department of Data Science
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
03-3542-2511
Homepage URL
tmisumi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
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, Japan
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Tel
+81-04-7133-1111
irst@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
| 2023 | Year | 06 | Month | 02 | 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
| 2021 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a database study for integrated data of patients who participated in past clinical trials already stored in ARCAD-Asia database and ARCAD-Global database. The target patients of this study are not set because it is a secondary use of individual patient data already obtained in the each database.
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058385
