UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations
Acronym	Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations
Scientific Title	Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations
Scientific Title:Acronym	Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	1) To explore the correlation between the ctDNA dynamics and the response to Osimertinib 2) To examine the role of MCA (multiple-type ctDNA analysis) in monitoring clonal evolution during treatments including development of acquired resistance
Basic objectives2	Others
Basic objectives -Others	Diagnositic value
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) The rate at which the marker ctDNA is determined in the patients with EGFR-mutant NSCLC 2) Time course of the marker ctDNA change during Osimertinib treatment 3) Comparison of the mutations including T790M and C797S between cancer tissue DNA and ctDNA 4) Comparison of the allelic frequency (AF) of the mutations between cancer tissue DNA and ctDNA 5) Correlation between radiologic response to Osimertinib and AF in cancer tissue DNA and ctDNA at the start of the treatment with Osimertinib 6) Time course of ctDNA during Osimertinib treatment and resistance mechanism to Osimertinib in view of ctDNA
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Blood examination
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	I.Patients with histologically or cytologically confirmed EGFR-mutant (Ex19 deletion or L858R) NSCLC II.Patients who are planning to receive Osimertinib. III.Sufficient functions of the main organs IV.PS 0-2 at the start of the treatment with Osimertinib V.Submission of written informed consent concerning study participation
Key exclusion criteria	Patients judged by the investigator to be unsuitable for the study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Fumio Middle name Last name Imamura
Organization	Osaka International Cancer Institute
Division name	Department of Thoracic Oncology
Zip code	541-8567
Address	3-1-69 Otemae, CHuo-ku, Osaka 541-8567
TEL	+81-6-6945-1181
Email	imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Fumio Middle name Last name Imamura
Organization	Osaka International Cancer Institute
Division name	Department of Thoracic Oncology
Zip code	541-8567
Address	3-1-69 Otemae, CHuo-ku, Osaka 541-8567
TEL	+81-6-6945-1181
Homepage URL
Email	imamura-fu@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	AstraZeneca
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	Osaka International Cancer Institute
Address	Osaka International Cancer Institute
Tel	0669721181
Email	imamura-fu@mc.pref.osaka.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	2017 Year 09 Month 10 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	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 10 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 04 Day
Last modified on	2020 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033171