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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046072
Receipt No. R000052280
Scientific Title Exploratory observational study of the effects of EGFR-TKIs on NLRs
Date of disclosure of the study information 2021/11/15
Last modified on 2021/11/15

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Basic information
Public title Exploratory observational study of the effects of EGFR-TKIs on NLRs
Acronym Exploratory observational study of the effects of EGFR-TKIs on NLRs
Scientific Title Exploratory observational study of the effects of EGFR-TKIs on NLRs
Scientific Title:Acronym Exploratory observational study of the effects of EGFR-TKIs on NLRs
Region
Japan

Condition
Condition EGFR+ NSCLC
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to use EGFR-TKI in subjects who met the patient selection criteria among patients who started treatment with EGFR-TKI as a first-line drug for EGFR mutation-positive non-small cell lung cancer. To investigate the effects on NLR (neutrophil-lymphocyte ratio) and efficacy (tumor shrinkage effect (ORR) and progression-free survival (PFS)).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Relaiton of NLR and ORR/PFS
Key secondary outcomes Relation of NLR and OS

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
99 years-old >=
Gender Male and Female
Key inclusion criteria 1) NSCLC Adeno
2) Stage III/IV + After Ope
3) EGFR+ (Ex19del or L858R)
4) Locally Advanced or Metastatic Chemo Naive
5) Age>=20
6)PS:0-2
7) Not double cancer
8)Sufficient function(Liver,Kidney,CV)
9)EGFR-TKI started 2/1/2015-1/31/2020
Key exclusion criteria Not Eligible
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hiroshige
Middle name
Last name Yoshioka
Organization Kansai Medical University
Division name Department of Respiratory Oncology
Zip code 573-1191
Address 2-3-1 Shinmachi, Hirakata
TEL 072-804-0101
Email hgyoshioka@gmail.com

Public contact
Name of contact person
1st name Hiroshige
Middle name Yoshioka
Last name Yoshioka
Organization Kansai Medical University
Division name Department of Respiratory Oncology
Zip code 573-1010
Address 2-5-1,Shinmachi,Hirakata
TEL 0728040101
Homepage URL
Email hgyoshioka@gmail.com

Sponsor
Institute Kansai Medical University
Department of Respiratory Oncology
Institute
Department

Funding Source
Organization Delta-Fly Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai Medical University, Clinical Study Ethics Committee
Address 2-5-1,Shinmachi, Hirakata
Tel 0728040101
Email hgyoshioka@gmail.com

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 関西医科大学附属病院

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 15 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
2021 Year 10 Month 01 Day
Date of IRB
2021 Year 11 Month 09 Day
Anticipated trial start date
2021 Year 11 Month 25 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2021 Year 11 Month 15 Day
Last modified on
2021 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052280

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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