UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028990 |
|---|---|
| Receipt number | 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 08:40:22 |
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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
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
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033171
