UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028990
Receipt No. R000033171
Scientific Title Analysis of response and acquired resistance to EGFR-TKI by multiple circulating tumor DNA with cancer-specific gene mutations
Date of disclosure of the study information 2017/09/10
Last modified on 2020/09/07

* 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 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/ctr_e/ctr_view.cgi?recptno=R000033171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.