UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041252 |
|---|---|
| Receipt number | R000047107 |
| Scientific Title | The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments |
| Date of disclosure of the study information | 2020/07/29 |
| Last modified on | 2021/01/27 09:30:46 |
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Basic information
Public title
The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Acronym
The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Scientific Title
The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Scientific Title:Acronym
The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of EGFR-TKI resistance mechanism by each treatment
Basic objectives2
Others
Basic objectives -Others
Frequency of resistance mechanism due to gene mutation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of each resistant mechanisms to EGFR-TKI
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients who analyzed for the resistant mechanism to EGFR-TKI
Key exclusion criteria
Patients who excluded from studies
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
236-0004
Address
Kanazawaku, Yokohama
TEL
+81453527962
nkobayas@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University
Division name
Department of Pulmonogy
Zip code
2360004
Address
3-9 Fukuura, Kanazawaku, Yokohama
TEL
+81453527962
Homepage URL
nkobayas@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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
None
Address
None
Tel
None
None
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
| 2020 | Year | 07 | Month | 29 | 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
| 2020 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Search
Studyies will be systematically searched through PubMed, the Cochrane database and Web of Science as of July 29, 2020.
The search strategy for PubMed will be as follows:
(resistance OR resistant) AND (egfr OR epidermal growth factor receptor) AND (lung cancer [Title] OR lung carcinoma [Title] OR NSCLC[Title])
Limit English
The search strategy for Web of science will be as follows:
#1 TS= ((resistance OR resistant) AND (egfr OR epidermal growth factor receptor))
#2 TI= (lung cancer OR lung carcinoma OR NSCLC)
#3 #1 AND #2
Limit English
The search strategy for Cochrane will be as follows:
#1 All Text = ((resistance OR resistant) AND (egfr OR epidermal growth factor receptor))
#2 Title Abstract Keyword = (lung cancer OR lung carcinoma OR NSCLC)
#3 #1 AND #2
Excluding Cochrane review and Cochrane protocol
Reference lists in the included articles and review articles will be also hand searched.
Data synthesis
The incidence of resistant mechanisms will be pooled. Synthesized data will be analyzed with each EGFR-TKIs.
Statistical significance will be judged by P < 0.05.
Management information
Registered date
| 2020 | Year | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047107
