UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033969 |
|---|---|
| Receipt number | R000038704 |
| Scientific Title | Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study) |
| Date of disclosure of the study information | 2018/08/31 |
| Last modified on | 2022/09/02 10:09:08 |
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Basic information
Public title
Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Acronym
Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Scientific Title
Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Scientific Title:Acronym
Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the change in clonal heterogeneity between afatinib and gefitinib therapy, and to investigate the correlation of the change in clonal heterogeneity with the efficacy of osimertinib.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in clonal heterogeneity upon afatinib or gefinitib treatment.
Key secondary outcomes
The correlation of the clonal heterogeneity with the efficacy of osimertinib.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Scheduled for osimertinib therapy (80mg/day, daily)
2)To collect an additional 17mL blood before osimertinib therapy is acceptable
3)FFPE tissue sample before afatinib or gefitinib therapy is available
4)Confirmed T790M acquisition at disease progression at 1st line afatinib or gefitinib therapy
5)FFPE tissue sample at the time of disease progression to afatinib or gefitinib therapy is available
6)ECOG performance status: 0 to 2
7)Life expectancy longer than 3 months
8)Adequate organ functions
9)Written informed consent
10)Age >=20 years and <70 years
Key exclusion criteria
1)Administrated other EGFR-TKI before afatinib or gefitinib treatment as 1st line therapy
2)Administrated afatinib or gefitinib as 1st line therapy and recieved other anti-tumor medicine after disease progression before prior to osimertinib therapy
3)Interstitial lung disease or pulmonary fibrosis
4)Active double cancers
5)Uncontrolled abdominal or pericardial effusion or ascites
6)With the following severe comorbidities
-Uncontrolled angina, cardiac infarct within three month, or heart failure
-Uncontrolled diabetes or hypertension
-Severe infection or comorbidities
-Significant or recent gastrointestinal disorders whose main symptom is diarrhea
-Other complications (e.g. ileus) judged to pose serious obstacles to osimeltinib therapy
7)Women who are pregnant, planning to become pregnant, or breast-feeding. Patients who are unwilling to use contraceptives
8)Patients whose physician assessed inappropriate to the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Miyako |
| Middle name | |
| Last name | Satouchi |
Organization
Hyogo Cancer Center
Division name
Department of Thoracic Oncology
Zip code
6738558
Address
13-70, Kitaoji-cho, Akashi, Hyogo
TEL
078-929-1151
satouchi@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hattori |
Organization
Hyogo Cancer Center
Division name
Department of Thoracic Oncology
Zip code
6738558
Address
13-70, Kitaoji-cho, Akashi, Hyogo
TEL
078-929-1151
Homepage URL
hattori@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co ., Ltd.
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
The ethical review boards in Hyogo Cancer Center
Address
13-70, Kitaoji-cho, Akashi, Hyogo
Tel
078-929-1151(ext.440)
hcc-irb@hyogo-cc.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
| 2018 | Year | 08 | Month | 31 | 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
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the change in clonal heterogeneity between afatinib and gefitinib therapy, and to investigate the correlation of the change in clonal heterogeneity with the efficacy of osimertinib.
Management information
Registered date
| 2018 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038704
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
