UMIN-CTR Clinical Trial

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for SCRUM-Japan related study*1 has been obtained, and consent for secondary use, including commercial use, has not been revoked 2) Diagnostic confirmation as one of the following cancer types: 1.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
Email	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
Email	hbando@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052472