UMIN-CTR Clinical Trial

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
Institute	HANSHIN Oncology Group
Institute
Department

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
URL(English)	https://upload.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

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