UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040759
Receipt number R000046540
Scientific Title Mechanism of resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) among lung cancer patients with EGFR mutant
Date of disclosure of the study information 2020/06/14
Last modified on 2020/07/29 18:26:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Mechanism of resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) among lung cancer patients with EGFR mutant

Acronym

Mechanism of resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) among lung cancer patients with EGFR mutant

Scientific Title

Mechanism of resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) among lung cancer patients with EGFR mutant

Scientific Title:Acronym

Mechanism of resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) among lung cancer patients with EGFR mutant

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the frequency 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 enrolled the phase 2 or 3 clinical trials about EGFR-TKI

Key exclusion criteria

Patients who excluded from clinical trials

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

Email

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


Email

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

Email

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 06 Month 14 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 06 Month 10 Day

Date of IRB

2020 Year 06 Month 26 Day

Anticipated trial start date

2020 Year 06 Month 14 Day

Last follow-up date

2020 Year 07 Month 28 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, EMBASE, and Web of Science as of June 14, 2020. The search strategy for PubMed will be as follows:
#1 (resistance or resistant) and (egfr or epidermal growth factor receptor)
#2 (cancer [title] or carcinoma [title])
#1 and #2.
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 06 Month 14 Day

Last modified on

2020 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name