UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041474 |
|---|---|
| Receipt number | R000047342 |
| Scientific Title | The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton (L858R and delition 19): HOPE-002 |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2020/08/24 15:57:19 |
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Basic information
Public title
The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton (L858R and delition 19): HOPE-002
Acronym
The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton: HOPE-002
Scientific Title
The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton (L858R and delition 19): HOPE-002
Scientific Title:Acronym
The predictive marker for detecting T790M from a patient background before treatment in stage4 NSCLC patients harboring EGFR mutaiton: HOPE-002
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluate the predictive marker for detecting T790M from the patient background in stage4 NSCLC patients harbering EGFR mutation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the predictive marker for detecting T790M from the patient background in stage4 NSCLC patients harbering EGFR mutation
Key secondary outcomes
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
stage4 NSCLC
EGFR mutation (L858R or deliton10) positive
Key exclusion criteria
recurrent patient
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Tamiya |
Organization
Osaka International Cancer Institute
Division name
Thoracic Oncology
Zip code
541-8567
Address
3-1-69 Otemae Chuo-ku Osaka
TEL
06-6945-1181
moto19781205@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Tamiya |
Organization
Osaka International Cancer Institute
Division name
Thoracic Oncology
Zip code
541-8567
Address
3-1-69 Otemae Chuo-ku Osaka
TEL
06-6945-1181
Homepage URL
moto19781205@yahoo.co.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
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
3-1-69 Otemae Chuo-ku Osaka
Tel
06-6945-1181
moto19781205@yahoo.co.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 | 08 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2020 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047342
