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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024935
Receipt No. R000028688
Scientific Title exosome-focused translational research for afatinib
Date of disclosure of the study information 2017/01/01
Last modified on 2018/09/13

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Basic information
Public title exosome-focused translational research for afatinib
Acronym EXTRA
Scientific Title exosome-focused translational research for afatinib
Scientific Title:Acronym EXTRA
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Effects of various exosome-encapsulating molecules (DNA, proteins, metabolites, etc.) in blood, on the therapeutic effect and tolerance acquisition of afatinib in EGFR gene mutation positive non-small cell lung cancer (NSCLC) patients were analyzed by various OMICs analysis / Trans- Consider by OMICs analysis.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Identification of pharmacological markers and resistance factors of afatinib using exosome-derived molecules
Key secondary outcomes Relationship between various factors and response rate, disease control ratio, progression-free survival time, overall survival time
Consideration of compatibility of results between serum specimen and serum exosome specimen

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 non small cell lung cancer
diagnosed adenocarcinoma
having Ex19 mutation, Ex.21 mutation, uncommon mutation
using afatinib as first line treatment
ECOG PS 0,1
healthy patient
It is expected to survive for at least 3 months.
writing consent is obtained
Key exclusion criteria Illegal disorders such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug pneumonia, etc. are complicated
synchronous or allochronic malignancies
having the history of preoperative anticancer treatments
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Seki
Organization Teikyo University School of Medicine
Division name internal medicine
Zip code
Address 2-11-1 Kaga, Itabashi-ku Tokyo
TEL 03-3964-1231
Email nseki@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL 03-3964-1231
Homepage URL http://teikyohaigeka.com/
Email matsutan@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
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
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 帝京大学(東京都)
都立駒込病院(東京都)
虎ノ門病院(東京都)
慶應義塾大学(東京都)
東京医科大学(東京都)
東京医科大学八王子医療センター(東京都)
東京女子医科大学(東京都)
日本大学医学部附属板橋病院(東京都)
国立病院機構 弘前病院(青森県)
弘前大学(青森県)
浜松医科大学(静岡県)
山形県立中央病院(山形県)
埼玉県立循環器・呼吸器病センター(埼玉県)
星ヶ丘医療センター(大阪府)
国立病院機構 水戸医療センター(茨城県)
国立病院機構 茨城東病院(茨城県)
岡山赤十字病院(岡山県)
川崎医科大学附属川崎病院(岡山県)
伊勢赤十字病院(三重県)
昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information blood sampling

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028688

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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