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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019446
Receipt No. R000022480
Scientific Title A study of biomarkers that predict efficacy of or resistance to trastuzumab emtansine for patients with HER2-positive non-small cell lung cancer
Date of disclosure of the study information 2015/10/21
Last modified on 2015/10/21

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Basic information
Public title A study of biomarkers that predict efficacy of or resistance to trastuzumab emtansine for patients with HER2-positive non-small cell lung cancer
Acronym Biomarker study of T-DM1 for HER2-positive non-small cell lung cancer
Scientific Title A study of biomarkers that predict efficacy of or resistance to trastuzumab emtansine for patients with HER2-positive non-small cell lung cancer
Scientific Title:Acronym Biomarker study of T-DM1 for HER2-positive non-small cell lung cancer
Region
Japan

Condition
Condition HER2-positive, recurrent, non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore potential biomarkers related to efficacy of or resistance to T-DM1 for patients with HER2-positive non-small cell lung cancer
Basic objectives2 Others
Basic objectives -Others Biomarker study
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Identification of biomarkers related to efficacy of or resistance to T-DM1 for patients with HER2-positive non-small cell lung cancer
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Enrolled on a study of trastuzumab emtansine in patients with HER2-positive recurrent metastatic non-small cell lung cancer (HER2-CS-2 study)
(2)Written informed consent
Key exclusion criteria There are no special instruction regarding this section.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Kiura
Organization Okayama University Hospital
Division name Allergy and respiratory medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-Ku,Okayama
TEL 086-235-7227
Email kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroe Kayatani
Organization Okayama University Hospital
Division name Allergy and respiratory medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-Ku,Okayama
TEL 086-235-7227
Homepage URL
Email hk64hk85@yahoo.co.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Allergy and respiratory medicine, Okayama University Hospital
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 10 Month 21 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will evaluate several protein levels in serum and cancer-related genes within the tumor tissue from patients with HER2 positive non-small cell lung cancer who enrolled in HER2-CS-2 study, and will explore potential biomarkers related to efficacy of or resistance to T-DM1.

Management information
Registered date
2015 Year 10 Month 21 Day
Last modified on
2015 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022480

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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