UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043305 |
|---|---|
| Receipt number | R000049443 |
| Scientific Title | Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2021/02/12 |
| Last modified on | 2021/08/13 15:21:24 |
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Basic information
Public title
Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer
Acronym
IO-BMI study
Scientific Title
Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer
Scientific Title:Acronym
Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer
Region
| Japan |
Condition
Condition
Patients that diagnosed as advanced / recurrent non-small cell lung cancer, and received immunotherapy at our hospital
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We explore the relationship between the effects of immunotherapy and BMI before treatment in patients with advanced / recurrent non-small cell lung cancer.
Basic objectives2
Others
Basic objectives -Others
We explore the relationship between the effects of immunotherapy and background factors before treatment in patients with advanced / recurrent non-small cell lung cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between overall survival and pretreatment BMI
Key secondary outcomes
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
A patient diagnosed as advanced / recurrent non-small cell lung cancer.
A patient in which immunotherapy (immune checkpoint inhibitor alone or combined immunotherapy using a combination of immune checkpoint inhibitor and chemotherapy) was performed in our hospital.
Key exclusion criteria
A patient in which information on background factors such as effects and BMI cannot be collected
Target sample size
150
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
022-290-8850
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
0222908850
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
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, Faculty of Medicine
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
| 2021 | Year | 02 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2021 | Year | 02 | Month | 11 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049443
| 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 |
