UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040474 |
|---|---|
| Receipt number | R000046145 |
| Scientific Title | Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study- |
| Date of disclosure of the study information | 2020/05/25 |
| Last modified on | 2021/10/08 17:20:05 |
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Basic information
Public title
Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study- (WJOG13119L)
Acronym
Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy - a multicenter collaborative study-
Scientific Title
Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study-
Scientific Title:Acronym
Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy - a multicenter collaborative study-
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the time to treatment failure of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups detected by droplet digital PCR methods.
Basic objectives2
Others
Basic objectives -Others
Time to treatment failure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to treatment failure of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups detected by dd-PCR methods.
Key secondary outcomes
Time to treatment failure between different generations of EGFR-TKIs in patients with or without pretreatment EGFR T790M detected by dd-PCR.
Progression free survival of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups by dd-PCR methods.
Examination of the appropriate cut-off value of EGFR T790M allele frequency for the efficacy of EGFR-TKIs.
T790M mutation detection ability after acquired resistance between Cobas and dd-PCR methods.
T790M mutation allele frequency by dd-PCR methods in pretreatment tumor tissue samples between T790M positive and negative groups by Cobas after acquired resistance.
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 confirmed non-squamous non-small cell lung cancer
2) Confirmed EGFR mutations (exon 19 deletion, exon 21 L858R) in tumor tissue samples taken after April 2015
3) Confirmed EGFR exon20 T790M negative in pretreatment tumor tissue samples
4) Stage III or IV not suitable to radical radiation therapy. Recurrence after operation or chemoradiotherapy.
5) EGFR-TKI treatment naive, previous treatment with at least one chemotherapy regimen
6) Provision of archival tumor tissue obtained prior to EGFR-TKI treatment
Key exclusion criteria
1) Confirmed EGFR exon19 deletion or exon21 L858R plus other EGFR gene mutations
2) Switching to another EGFR-TKI between different generations
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Hattori |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Internal Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5196
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.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
| 2020 | Year | 05 | Month | 25 | 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
360
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
| 2020 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target sample size is 360. (The target sample for each first, second and third generation EGFR-TKI is 120 cases, respectively.)
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046145
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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