UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037294
Receipt number R000042517
Scientific Title Study on EGFR tyrosine kinase inhibitor drug Osimertinib resistance in EGFR mutant NSCLC for analysis of immunohistochemistory of tumor tissues.
Date of disclosure of the study information 2019/07/06
Last modified on 2021/11/29 14:59:40

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Basic information

Public title

Study on EGFR tyrosine kinase inhibitor drug Osimertinib resistance in EGFR mutant NSCLC for analysis of immunohistochemistory of tumor tissues.

Acronym

Study on Osimertinib resistance mechanism

Scientific Title

Study on EGFR tyrosine kinase inhibitor drug Osimertinib resistance in EGFR mutant NSCLC for analysis of immunohistochemistory of tumor tissues.

Scientific Title:Acronym

Study on Osimertinib resistance mechanism

Region

Japan North America


Condition

Condition

Lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To discover the novel resistant mechanism to Osimertinib

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Novel resistant mechanism to Osimertinib

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Pathologically diagnosed with non-small cell lung cancer
2)Harboring EGFR mutation
3)Prior treatment history with Osimertinib
4)Adequate histological sample after resistance to Osimertinib
5)Provided informed consent

Key exclusion criteria

None

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takehito
Middle name
Last name Shukuya

Organization

Juntendo University

Division name

Respiratory Medicine

Zip code

113-8431

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1063

Email

tshukuya@juntendo.ac.jp


Public contact

Name of contact person

1st name Keita
Middle name
Last name Miura

Organization

Juntendo University

Division name

Respiratory Medicine

Zip code

113-8431

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1063

Homepage URL


Email

k-miura@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo University

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

Juntendo University

Address

3-1-3, Hongo, Bunkyo-ku, Tokyo

Tel

03-5802-1584

Email

kenkyu5858@juntendo.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 07 Month 06 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

0

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

2019 Year 06 Month 21 Day

Date of IRB

2019 Year 06 Month 21 Day

Anticipated trial start date

2019 Year 07 Month 06 Day

Last follow-up date

2021 Year 10 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2019 Year 07 Month 06 Day

Last modified on

2021 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042517


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name