UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035642 |
|---|---|
| Receipt number | R000040604 |
| Scientific Title | Biomarker study using cell-free DNA from lEGFR T790M-positive ung adenocarcinoma patients who receive osimertinib + ramucirumab after EGFR-TKI failure |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2022/01/25 19:37:54 |
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Basic information
Public title
Biomarker study using cell-free DNA from lEGFR T790M-positive ung adenocarcinoma patients who receive osimertinib + ramucirumab after EGFR-TKI failure
Acronym
Biomarker study in adenocarcinoma patients who receive osimertinib + ramucirumab
Scientific Title
Biomarker study using cell-free DNA from lEGFR T790M-positive ung adenocarcinoma patients who receive osimertinib + ramucirumab after EGFR-TKI failure
Scientific Title:Acronym
Biomarker study in adenocarcinoma patients who receive osimertinib + ramucirumab
Region
| Japan |
Condition
Condition
lung adenocarcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Establishment of detection of gene mutation using peripheral blood from lung cancer and investigation of its clinical significance
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance between tumor tissue and cell-free DNA
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
Patients who participate in phase I study of osimertinib and ramucirumab and who can provide blood sample and tisuue sample.
Key exclusion criteria
None
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Koh |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
Address
8-1-1 Kimiiidera, Wakayama
TEL
0734410619
ykoh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Koh |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
Address
8-1-1 Kimiiidera, Wakayama
TEL
0734410619
Homepage URL
ykoh@wakayama-med.ac.jp
Sponsor or person
Institute
Eli Lilly
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly
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
Address
Tel
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
| 2019 | Year | 01 | Month | 24 | 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
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Serial monitoring of mutational status in the plasma DNA during the treatment with osimertinib and ramucirumab
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040604
