UMIN-CTR Clinical Trial

Basic information
Public title	validation study of cancer-related diagnosis and outcomes on Japanese electronic medical records
Acronym	validation study of oncology disease area
Scientific Title	alidation study of cancer-related diagnosis and outcomes on Japanese electronic medical records
Scientific Title:Acronym	validation study of oncology disease area
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Gastroenterology Pneumology Hematology and clinical oncology Gastrointestinal surgery Chest surgery Breast surgery Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop algorithms for identifying patients with Cancer and related outcomes in the Real World Data (RWD) database
Basic objectives2	Others
Basic objectives -Others	Sensitivity, specificity, positive predictive value, and negative predictive value of cancer-related outcomes
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity, specificity, positive predictive value, and negative predictive value of cancer related outcomes
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	Not applicable
Key exclusion criteria	Not applicable
Target sample size	450

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kanemitsu
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Division name	Medical Affairs
Zip code	103-8324
Address	1-1 Nihonbashi-Muromach 2-chome, Chuo-ku Tokyo
TEL	03-3273-0833
Email	kanemitsutks@chugai-pharm.co.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kanemitsu
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Division name	Medical Affairs
Zip code	103-8324
Address	1-1 Nihonbashi-Muromach 2-chome, Chuo-ku Tokyo
TEL	03-3273-0833
Homepage URL
Email	kanemitsutks@chugai-pharm.co.jp

Sponsor
Institute	Kurashiki Central Hospital, Kurashiki
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd
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	Research Institute of Healthcare Data Science
Address	12th floor, Sumitomo Shiba Daimon Building 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel	03-5733-5010
Email	rihds@jmdc.co.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 02 Month 03 Day

Related information
URL releasing protocol	https://bmjopen.bmj.com/content/12/7/e055459.long
Publication of results	Published

Result
URL related to results and publications	https://bmjopen.bmj.com/content/12/7/e055459.long
Number of participants that the trial has enrolled	450
Results	https://bmjopen.bmj.com/content/12/7/e055459.long
Results date posted	2022 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 07 Month 13 Day
Baseline Characteristics	https://bmjopen.bmj.com/content/12/7/e055459.long
Participant flow	https://bmjopen.bmj.com/content/12/7/e055459.long
Adverse events	https://bmjopen.bmj.com/content/12/7/e055459.long
Outcome measures	https://bmjopen.bmj.com/content/12/7/e055459.long
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 12 Month 28 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 01 Month 17 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 04 Month 08 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2020 Year 12 Month 16 Day

Other
Other related information	None

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2022 Year 08 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044875