UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039345 |
|---|---|
| Receipt number | R000044875 |
| Scientific Title | alidation study of cancer-related diagnosis and outcomes on Japanese electronic medical records |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2022/08/05 16:49:43 |
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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 |
| Obstetrics 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
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
kanemitsutks@chugai-pharm.co.jp
Sponsor or person
Institute
Kurashiki Central Hospital, Kurashiki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
