UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045973 |
|---|---|
| Receipt number | R000052472 |
| Scientific Title | A Study for Building a Real-World Database of Cancer Patients in Japan |
| Date of disclosure of the study information | 2021/11/04 |
| Last modified on | 2021/11/03 19:14:59 |
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Basic information
Public title
A Study for Building a Real-World Database of Cancer Patients in Japan
Acronym
A Study for Building a Real-World Database of Cancer Patients in Japan
Scientific Title
A Study for Building a Real-World Database of Cancer Patients in Japan
Scientific Title:Acronym
A Study for Building a Real-World Database of Cancer Patients in Japan
Region
| Japan |
Condition
Condition
Esophageal cancer, stomach, and esophagogastric junction cancers, Colorectal cancer, Hepatocellular carcinoma, Pancreatic cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to create a real-world database (RWD) for National Cancer Center Hospital East to improve cancer treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival, Progression free surviva, Time to treatment failure, Frequency of various types of adverse events experienced during treatment
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
1) Consent of the patient participating in the study has been confirmed through one of the following forms:
1. Written consent specific to this study has been obtained for participation in this study
2. Consent for SCRUM-Japan related study*1 has been obtained, and consent for secondary use, including commercial use, has not been revoked
2) Diagnostic confirmation as one of the following cancer types:
1. Esophageal cancer, stomach, and esophagogastric junction cancers
2. Colorectal cancer
3. Hepatocellular carcinoma
4. Pancreatic cancer
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Ohtsu |
| Middle name | |
| Last name | Atsushi |
Organization
National Cancer Center Hospital East
Division name
Hospital Director
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
aohtsu@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Bando |
| Middle name | |
| Last name | Hideaki |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
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 Hospital East
Institute
Department
Personal name
Funding Source
Organization
Flatiron Health
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
National Cancer Center Institutional Review Board
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Tel
04-7133-1111
IRBsupport@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
| 2021 | Year | 11 | 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
| 2021 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to create a real-world database (RWD) for National Cancer Center Hospital East to improve cancer treatment. This includes viewing, processing, and analyzing patient-level data such as the patient background, diagnostic information, disease severity, laboratory values, treatment, and patient outcomes. The created database is used to facilitate the analysis of real-world cancer treatments, including the formulation of hypotheses, observational studies, and an assessment of the overall suitability of RWD used in various studies.
Management information
Registered date
| 2021 | Year | 11 | Month | 03 | Day |
Last modified on
| 2021 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052472
