UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037777 |
|---|---|
| Receipt number | R000043080 |
| Scientific Title | Efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma: multicenter retrospective observational study |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2022/02/22 21:47:23 |
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Basic information
Public title
Efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma: multicenter retrospective observational study
Acronym
Efficacy of ICI in patients with NSCLC other than adenocarcinoma or squamous cell carcinoma in a multi-center retrospective study
Scientific Title
Efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma: multicenter retrospective observational study
Scientific Title:Acronym
Efficacy of ICI in patients with NSCLC other than adenocarcinoma or squamous cell carcinoma in a multi-center retrospective study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of immune checkpoint inhibitors on non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who had unresectable non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma, and all patients received with immune checkpoint inhibitors
Key exclusion criteria
Patients with no or insufficient clinical information
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192 JAPAN
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Miyashita |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192 JAPAN
TEL
053-435-2263
Homepage URL
miya501@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu university school of medicine Research cooperation section research support staff
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192 JAPAN
Tel
053-435-2111
rinri@hama-med.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
| 2019 | Year | 08 | Month | 22 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center retrospective observational study
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043080
