UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030356 |
|---|---|
| Receipt number | R000034661 |
| Scientific Title | A prospective study to evaluate the reduction of PD-L1 expression due to sample age in patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2021/06/14 18:17:31 |
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Basic information
Public title
A prospective study to evaluate the reduction of PD-L1 expression due to sample age in patients with non-small cell lung cancer
Acronym
A prospective study to evaluate PD-L1 expression due to sample age in patients with non-small cell lung cancer
Scientific Title
A prospective study to evaluate the reduction of PD-L1 expression due to sample age in patients with non-small cell lung cancer
Scientific Title:Acronym
A prospective study to evaluate PD-L1 expression due to sample age in patients with non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the reduction of PD-L1 expression due to aging degradation of tissue specimens in patients with non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PD-L1 expression in tumor tissue one year after first evaluation
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age of 20 years old and older than 20
years old.
2)Histologically and/or cytologically proven non-small cell lung cancer.
3)Sufficient tumor cells in tissue specimens to evaluate PD-L1 expression (over 100 Viable tumor cells).
4)PD-L1 expression has been evaluated within 3 months of tumor tissue harvest.
Key exclusion criteria
1)Dementia or psychological disorder difficult to participate in this clinical study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujimoto Daichi |
Organization
Kobe city medical center general hospital
Division name
Respiratory medicine
Zip code
Address
2-1-1,minatojima minamimachi,chuuouku,Kobe city
TEL
078-302-4321
daichi@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawachi Hayato |
Organization
Kobe city medical center general hospital
Division name
Respiratory medicine
Zip code
Address
2-1-1,minatojima minamimachi,chuuouku,Kobe city
TEL
078-302-4321
Homepage URL
kwhat0729@gmail.com
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe city medical center general hospital
Department of Respiratory 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
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
| 2017 | Year | 12 | Month | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Non-small cell lung cancer patients who consult Kobe city medical center general hospital after January 2016 and who is eligible for the inclusion criteria
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034661
