UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024935 |
|---|---|
| Receipt number | 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 10:26:08 |
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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
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/
matsutan@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028688
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
