UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054934 |
|---|---|
| Receipt number | R000062719 |
| Scientific Title | Development of a real-world database for cancer patients in Japan |
| Date of disclosure of the study information | 2024/07/11 |
| Last modified on | 2025/10/07 17:16:35 |
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Basic information
Public title
Development of a real-world database for cancer patients in Japan
Acronym
Development of a real-world database for cancer patients in Japan
Scientific Title
Development of a real-world database for cancer patients in Japan
Scientific Title:Acronym
Development of a real-world database for cancer patients in Japan
Region
| Japan |
Condition
Condition
- Breast cancer
- Thoracic malignancy (non-small cell lung cancer, small cell lung cancer, etc.)
- Gastrointestinal cancer (pancreatic cancer, liver cancer)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To curate high-quality oncology real-world data based on existing and future medical records at the Nagoya University Hospital, and to conduct research utilizing this RWD for the furtherance of research and medical care for cancer in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Real-world overall survival, time-to-next-treatment, progression-free survival, time-to-treatment-discontinuation etc.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included in this study:
1. Patients who received care at Nagoya University Hospital between January 1, 2011 and December 31, 2028
2. Patients with a confirmed diagnosis of any of the following tumor types:
- Breast cancer
- Thoracic malignancy (non-small cell lung cancer, small cell lung cancer,etc)
- Gastrointestinal cancer (pancreatic cancer, liver cancer)
3. Patients aged 18 and above
4. Patient(or a legal surrogate) has either confirmed willingness to participate in the study through one of the following methods, or has not expressed a decline to participate.
- Written informed consent has been obtained using study-specific explanatory and consent documents.
- For eligible patients who visited the Nagoya University Hospital on or after January 1, 2011, and are already deceased, no objection to participation has been received from the patient's legal surrogate after being provided with an opportunity to decline participation in this study,provided that this does not contradict the explicit wishes expressed by the patient during their lifetime.
Surrogate: Spouse, parents, siblings, children/grandchildren, grandparents, relatives living together with the subject patient, or persons considered to be equivalent to such close relatives (excluding minors).
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Maruyama |
Organization
Nagoya University Hospital
Division name
Hospital Director
Zip code
466-8560
Address
65 Tsurumai-cho, Nagoya-shi, Aichi Prefecture, Japan
TEL
052-741-2111
marus@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyone |
| Middle name | |
| Last name | Kikumori |
Organization
Nagoya University Hospital
Division name
Breast and Endocrine Surgery Department
Zip code
466-8560
Address
65 Tsurumai-cho, Nagoya-shi, Aichi Prefecture, Japan
TEL
052-741-2111
Homepage URL
kikumori@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Flatiron Health K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Flatiron Health K.K.
Name of secondary funder(s)
Nagoya University Hospital
IRB Contact (For public release)
Organization
Institutional Review Board of the Ethics Committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Nagoya-shi, Aichi Prefecture, Japan 466-8560
Tel
052-741-2111
ethics@med.nagoya-u.ac.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
| 2024 | Year | 07 | Month | 11 | 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
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062719
