UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043299
Receipt number R000049415
Scientific Title An ancillary biomarker study of Gio-Tag Japan.
Date of disclosure of the study information 2021/02/15
Last modified on 2021/02/10 19:18:25

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Basic information

Public title

An ancillary biomarker study of Gio-Tag Japan.

Acronym

An ancillary biomarker study of Gio-Tag Japan.

Scientific Title

An ancillary biomarker study of Gio-Tag Japan.

Scientific Title:Acronym

An ancillary biomarker study of Gio-Tag Japan.

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Identifying Factors that Make Patients Ready for Afatinib to Osimertinib Sequential Therapy

Basic objectives2

Others

Basic objectives -Others

Biomarker study

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Comparison of T790M rate before and after treatment with afatinib.

Key secondary outcomes

Correlation between T790M rate before treatment with afatinib and response rate, progression-free survival, and overall survival of afatinib.

Correlation between the T790M rate before the treatment with afatinib and the transition rate to second-line treatment.

Correlation between T790M rate before treatment with afatinib, and response rate and progression-free survival rate of second-line 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients enrolled in the main study (Gio-Tag Japan) (UMIN000037452)

Key exclusion criteria

Patients with no residual specimens collected in the main study (Gio-tag Japan)

Patients whose data was rejected in the main study

Target sample size

93


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Kijima

Organization

Hyogo College of Medicine Hospital

Division name

Respiratory Medicine

Zip code

663-8501

Address

1-1,mukogawacho,nishinomiya

TEL

0798-45-6597

Email

tkijima@hyo-med.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Yokoi

Organization

Hyogo College of Medicine Hospital

Division name

Respiratory Medicine

Zip code

663-8501

Address

1-1,mukogawacho,nishinomiya

TEL

0798-45-6597

Homepage URL


Email

ta-yokoi@hyo-med.ac.jp


Sponsor or person

Institute

HANSHIN 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

Hyogo College of Medicine

Address

1-1,mukogawacho,nishinomiya

Tel

0798-45-6066

Email

rinri@hyo-med.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

全国から約60施設


Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 15 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

93

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

No longer recruiting

Date of protocol fixation

2020 Year 09 Month 18 Day

Date of IRB

2020 Year 10 Month 26 Day

Anticipated trial start date

2020 Year 10 Month 26 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 07 Month 31 Day


Other

Other related information

Retrospective observational study


Management information

Registered date

2021 Year 02 Month 10 Day

Last modified on

2021 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name