UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042535 |
|---|---|
| Receipt number | R000048554 |
| Scientific Title | A medical economic analysis of cancer chemotherapy for patients with advanced lung cancer. |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2022/08/23 11:26:37 |
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Basic information
Public title
A medical economic analysis of cancer chemotherapy for patients with advanced lung cancer.
Acronym
Medical economic analysis of chemotherapy for patients with advanced lung cancer.
Scientific Title
A medical economic analysis of cancer chemotherapy for patients with advanced lung cancer.
Scientific Title:Acronym
medical economic analysis of chemotherapy for patients with advanced lung cancer.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Calculate the cost of 1st-line or 2nd-line chemotherapy including molecular target drugs, angiogenesis inhibitors and immune checkpoint inhibitors for improving prognosis in patients with advanced lung cancer. Then compare cost-effectiveness between each drug, and search for appropriate cancer chemotherapy medical economically.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
compare incremental cost effectiveness ratio between each drug as 1st-line or 2nd-line chemotherapy including molecular target drugs, angiogenesis inhibitors and immune checkpoint inhibitors for improving prognosis in patients with advanced lung cancer.
Key secondary outcomes
search for appropriate treatment in cost-effectiveness for patients with advanced lung cancer, according to each of histopathological type, driver mutation and expression of PD-L1.
Base
Study type
Others,meta-analysis etc
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
Between June, 2020 to December, 2022, anti-cancer drugs for patients with lung cancer has been approved by Ministry of Health, Labor and Welfare, JAPAN
Key exclusion criteria
Between June, 2020 to December, 2022, anti-cancer drugs for patients with lung cancer hasn't been approved yet, or rescission of approval by Ministry of Health, Labor and Welfare, JAPAN
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | takeshi |
| Middle name | |
| Last name | tamaki |
Organization
Kansai medical university
Division name
First Department of Internal Medicine
Zip code
570-8507
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
0669921001
tamakit@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Tamaki |
Organization
Kansai Medical University Medical Center
Division name
First Department of Internal Medicine
Zip code
570-8507
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
0669921001
Homepage URL
tamakit@takii.kmu.ac.jp
Sponsor or person
Institute
kansai medical university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Kansai Medical University Medical Center
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
Tel
0669921001
rinriirb@hirakata.kmu.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
| 2020 | Year | 11 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
I simulate it using an imaginary patient model without intending for a real patient in this study. The dose of the anti-cancer drug calculates using a patient model.
Management information
Registered date
| 2020 | Year | 11 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048554
