UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016418 |
|---|---|
| Receipt number | R000019067 |
| Scientific Title | Chemotherapy in Japanese advanced lung cancer patients: a descriptive study using database |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2018/01/01 08:14:16 |
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Basic information
Public title
Chemotherapy in Japanese advanced lung cancer patients: a descriptive study using database
Acronym
Chemotherapy in advanced lung cancer patients: a descriptive study
Scientific Title
Chemotherapy in Japanese advanced lung cancer patients: a descriptive study using database
Scientific Title:Acronym
Chemotherapy in advanced lung cancer patients: a descriptive study
Region
| Japan |
Condition
Condition
Advanced lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Describe the detail of chemotherapy regimens for advanced lung cancer patients in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of each chemotherapy regimen.
Key secondary outcomes
Overall survival, costs, adverse events of each chemotherapy regimen.
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
-Diagnosed with C34 in International Classification of Diseases, 10th revision (ICD-10) between 2004/1-2014/9
-Stage IIIB or IV
Key exclusion criteria
-18>
-Received thoracic radiotherapy within 8 days of 1st chemotherapy
-If they had any previously diagnosed cancers
-Did not survive at least 30 days past diagnosis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KATAOKA Yuki |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Healthcare Epidemiology
Zip code
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-753-4645
youkitikk@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KATAOKA Yuki |
Organization
Graduate School of Medicine and Public Health, Kyoto University
Division name
Department of Healthcare Epidemiology
Zip code
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-753-4645
Homepage URL
youkitikk@gmail.com
Sponsor or person
Institute
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
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
Address
Tel
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
| 2015 | Year | 02 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data extracted from database are birth date, gender, department, institution, Brinkman index, insurance, postal cord, height, weight, performance status, ICD-10 codes, EGFR mutation status, Alk mutation status, TNM, ADL score, comorbidity, white blood cells, neutrophil, hemoglobin, platelet, bilirubin, AST, ALT, BUN, creatinin, albumin, tested date, date administered chemotherapy, prescription of gefitinib, erlotinib, afatinib, S-1, UFT, crizotinib, alectinib, death date, and last admission date.
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | Day |
Last modified on
| 2018 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019067
