UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032055 |
|---|---|
| Receipt number | R000036569 |
| Scientific Title | tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer |
| Date of disclosure of the study information | 2018/04/02 |
| Last modified on | 2021/04/01 18:09:21 |
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Basic information
Public title
tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer
Acronym
CTC-BIOME
Scientific Title
tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer
Scientific Title:Acronym
CTC-BIOME
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between progression-free survival (PFS) with osimertinib and the expression of BIM-gamma mRNA in circulating tumor cells (CTC) in patients with EGFR mutation-positive lung cancer.
Basic objectives2
Others
Basic objectives -Others
To clarify biomarkers when administering osimertinib in patients with EGFR mutation-positive lung cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between BIM-gamma mRNA levels in CTC and PFS with osimertinib at baseline
Key secondary outcomes
1) Detection rate of mRNA and DNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR T790M, C797S, BIM-gamma, EL, L, and S) in CTC and cfDNA
2) Number of CTC extracted
3) Correlation between the expression of BIM-gamma mRNA in CTC and ORR with osimertinib
4) Correlation between the expression of mRNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA, EGFR, BIM-EL, L, and S) in CTC and PFS and ORR with osimertinib
5) Correlation between the expression of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR, BIM-gamma, EL, L, and S) in cfDNA and PFS and ORR with osimertinib
6) EGFR sensitive mutation and DNA expression of T790M in CTC and cfDNA
7) Detection rate of EGFR C797S mutation in CTC and cfDNA
8) Correlation between mRNA level of BIM-gamma in CTC and PFS of the patients with Osimertininb (during Osimertinib treatment)
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) Patients with advanced and postoperative recurrent NSCLC
2) Patients with EGFR sensitive mutation (Del 19, L858R mutation)
3) Patients with tolerance to EGFR-TKI (Gefitinib, Erlotinib, Afatinib) and EGFR T790M mutation
4) Patients with no history of prior treatment with osimertinib and other third-generation EGFR-TKIs
5) Patients who have given informed consent to participate in the study
6) Patients with ECOG performance status of 0 to 2
Key exclusion criteria
1) Patients with complications or a history of serious lung disorder
2) Patients with intermediate or serious liver disorder
3) Patients with complications or a history of serious QT prolongation (QTc value longer than 500msec, symptom of serious arrhythmia)
4) Pregnant women, women who may possibly be pregnant, women who hope to be pregnant, lactating women and men who declined contraception
5) Patients positive for human immunodeficiency virus (HIV)
6) Patients positive for HBs antigen or hepatitis C virus (HCV RNA)
7) Other patients considered as
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University School of Medicine
Division name
Division of Respiratory Medicine
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
kazutoshiisobe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Isobe |
Organization
Toho University School of Medicine
Division name
Division of Respiratory Medicine
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
kazutoshiisobe@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca Inc.
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
YES
Study ID_1
ESR-16-12403
Org. issuing International ID_1
AstraZeneca Inc.
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 | 04 | Month | 02 | 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 | 04 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
No information
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036569
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