UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050174 |
|---|---|
| Receipt number | R000057148 |
| Scientific Title | A retrospective study of the relationship between background factors and treatment efficacy/prognosis in patients with small cell lung cancer |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2023/01/29 20:36:20 |
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Basic information
Public title
A retrospective study of the relationship between background factors and treatment efficacy/prognosis in patients with small cell lung cancer
Acronym
SCLC RWD study
Scientific Title
A retrospective study of the relationship between background factors and treatment efficacy/prognosis in patients with small cell lung cancer
Scientific Title:Acronym
SCLC RWD study
Region
| Japan |
Condition
Condition
Cases pathologically diagnosed with small cell lung cancer at our hospital between February 2017 and December 2022
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between treatment effect/prognosis and background factors before treatment in patients with small cell lung cancer.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between treatment effect and background factors before treatment in patients with small cell lung cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between overall survival and pretreatment background factors
Key secondary outcomes
Relationship between treatment effect and background factors before treatment
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
Cases diagnosed with small cell lung cancer at our pathology department between February 2017 and December 2022.
For the above cases, treatment cases including only palliative therapy at the Department of Respiratory Medicine and Respiratory Surgery at our hospital.
Key exclusion criteria
Cases for which information on efficacy, prognosis, and background factors cannot be collected
Target sample size
83
Research contact person
Name of lead principal investigator
| 1st name | Naruo |
| Middle name | |
| Last name | Yoshimura |
Organization
Tohoku Medical and Pharmaceutical University, Faculty of Medicine
Division name
Division of Respiratory Medicine
Zip code
983-8536
Address
1-15-1, Komatsushima, Miyaginoku, Sendai, Miyagi, JAPAN
TEL
0222344181
y-naruo@sc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Naruo |
| Middle name | |
| Last name | Yoshimura |
Organization
Tohoku Medical and Pharmaceutical University, Faculty of Medicine
Division name
Division of Respiratory Medicine
Zip code
983-8536
Address
1-15-1, Komatsushima, Miyaginoku, Sendai, Miyagi, JAPAN
TEL
0222344181
Homepage URL
https://www.hosp.tohoku-mpu.ac.jp/center/cr_support_center/disclosure.html
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University, Tohoku Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Naro Yoshimura
Funding Source
Organization
Tohoku Medical and Pharmaceutical University, Tohoku Medical and Pharmaceutical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Medical and Pharmaceutical University Hospital
Address
1-15-1, Komatsushima, Miyaginoku, Sendai, Miyagi, JAPAN
Tel
0222908850
y-naruo@sc4.so-net.ne.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
| 2023 | Year | 02 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057148
