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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name