UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050590 |
|---|---|
| Receipt number | R000057622 |
| Scientific Title | Impact of Patient Background and Treatment Status on Outcomes and Prognosis of Cancer Patients in Real-world Clinical Practice: A retrospective cohort study using the Tokushukai Medical Database |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/23 10:08:45 |
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Basic information
Public title
Impact of Patient Background and Treatment Status on Outcomes and Prognosis of Cancer Patients in Real-world Clinical Practice: A retrospective cohort study using the Tokushukai Medical Database
Acronym
TREAD
Scientific Title
Impact of Patient Background and Treatment Status on Outcomes and Prognosis of Cancer Patients in Real-world Clinical Practice: A retrospective cohort study using the Tokushukai Medical Database
Scientific Title:Acronym
TREAD
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to analyze the overall survival, time to treatment failure, adverse events, patient background and comorbidities that affect the overall survival, time to treatment failure, and adverse events of cancer treatment including chemotherapy in clinical practice, and to clarify the actual treatment situation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival, time-to-treatment failure
Key secondary outcomes
Adverse effect, prognostic factor
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 newly diagnosed with cancer between April 1, 2010 and March 31, 2030 at any Tokushukai Group hospital in Japan that is subject to DPC and has the unified chemotherapy protocol system in place.
Key exclusion criteria
Patients who have requested not to participate in this study based on publicly available information.
Patients with active multiple cancers (synchronous multiple cancers and heterochronic multiple cancers with a disease-free interval of 5 years or less. However, active duplications do not include carcinoma in situ or intramucosal carcinomas that have been deemed cured by local treatment or lesions diagnosed as intraepithelial or intramucosal by endoscopic findings).
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Rai |
| Middle name | |
| Last name | Shimoyama |
Organization
Tokushukai medical group, Shonankamakura General Hospital
Division name
General surgery
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura city, Kanagawa JAPAN
TEL
0467-46-1717
rai.shimoyama@tokushukai.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Hayashi |
Organization
Mirai Iryo Research Center Inc.
Division name
(N/A)
Zip code
102-0074
Address
Tokyodouchiyoda build 15F, 1-3-1 kudanminami, Chiyoda-ku, Tokyo JAPAN
TEL
03-3263-4801
Homepage URL
https://www.shonankamakura.or.jp/department/trial/ongoing/
hayashi@mirai-iryo.com
Sponsor or person
Institute
Tokushukai Medical Group, General Incorporated Association Tokushukai
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodouchiyoda build 15F, 1-3-1 kudanminami, Chiyoda-ku, Tokyo JAPAN
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
湘南鎌倉総合病院（神奈川県）、湘南藤沢徳洲会病院（神奈川県）、八尾徳洲会総合病院（大阪府）、大垣徳洲会病院（岐阜県）、兵庫県立はりま姫路総合医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Retrospective cohort study
Eligible patients: Patients newly diagnosed with cancer between April 1, 2010 and March 31, 2030 at any Tokushukai Group hospital in Japan that is subject to DPC and has an anticancer drug protocol system.
Measurements: age (birth date), gender, ECOG-PS, drinking history, smoking history, height, weight, and body surface area (including date of measurement), date of last hospital visit, date of confirmation of survival, outcome and reason, planned or emergency hospitalization (including ICU admission), date of admission and discharge for planned or emergency hospitalization, outcome at discharge for planned or emergency hospitalization, and prescription (site, diagnostic code, tissue, and diagnosis), major medications based on prescription history, presence or absence of surgical, endoscopic, radiotherapy, chemotherapy, endocrine therapy, and other treatments and their details, presence or absence of general medical examinations including physical examinations and corporate examinations and their details, presence or absence of oxygen therapy, presence or absence of ventilator, presence or absence of ECMO, hospital name, diagnostic name (site, diagnosis code, tissue diagnosis, degree of differentiation), stage classification (cTNM, pTNM), date of initial diagnosis, treatment details, date of last confirmed survival, date of death, prognosis findings, date treatment started, date treatment ended, number of treatment cycles, treatment regimen, laboratory data before and during treatment for the patient (including dates of tests), and the patient's treatment period. Information obtained from DPC data on the patient's hospitalization during the treatment period, if any.
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057622
| 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 |
