UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056770 |
|---|---|
| Receipt number | R000064887 |
| Scientific Title | A retrospective study of GCSF administration in combination with platinum and immune checkpoint inhibitor therapy for extensive-stage small cell lung |
| Date of disclosure of the study information | 2025/01/21 |
| Last modified on | 2025/01/21 13:15:33 |
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Basic information
Public title
A retrospective study of GCSF administration in combination with platinum and immune checkpoint inhibitor therapy for extensive-stage small cell lung cancer
Acronym
A retrospective study of GCSF administration
Scientific Title
A retrospective study of GCSF administration in combination with platinum and immune checkpoint inhibitor therapy for extensive-stage small cell lung
Scientific Title:Acronym
A retrospective study of GCSF administration
Region
| Japan |
Condition
Condition
Extensive-stage small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of FN
Basic objectives2
Others
Basic objectives -Others
Overall survival, mortality rate due to infection, and use of GCSF preparations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of FN
Key secondary outcomes
Overall survival, mortality rate due to infection, and use of GCSF preparations
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
1. Small cell lung cancer has been diagnosed pathologically or cytologically.
2. Cases in which immune checkpoint inhibitors have been used in combination with platinum drugs
3. Treatment progress can be collected on a medical record
Key exclusion criteria
Cases that the principal investigator judged to be inappropriate for enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | TANAKA |
Organization
Hirosaki University Graduate School of Medicine,
Division name
Department of Respiratory Medicine
Zip code
0368562
Address
5
TEL
17239546
xyghx335@gmail.com
Public contact
Name of contact person
| 1st name | HISASHI |
| Middle name | |
| Last name | TANAKA |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
036
Address
5 Zaifucho, Hirosaki,
TEL
0172395468
Homepage URL
xyghx335@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
HISASHI TANAKA
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
Medical School Ethics Committee
Address
5 Zaifucho, Hirosaki,
Tel
0172-33-5111
rinri@hirosaki-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
| 2025 | Year | 01 | Month | 21 | 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
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2025 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064887
