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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026803
Receipt No. R000030771
Scientific Title Mass spectrometry-based proteogenomic investigation of protein-protein interaction networks and cancer-related pathways associated with NSCLC patients' EGFRm (+/-) status
Date of disclosure of the study information 2017/04/10
Last modified on 2020/08/06

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Basic information
Public title Mass spectrometry-based proteogenomic investigation of protein-protein interaction networks and cancer-related pathways associated with NSCLC patients' EGFRm (+/-) status
Acronym MS-based Proteogenomic study on molecular networks associated with EGFRm (+/-) status
Scientific Title Mass spectrometry-based proteogenomic investigation of protein-protein interaction networks and cancer-related pathways associated with NSCLC patients' EGFRm (+/-) status
Scientific Title:Acronym MS-based Proteogenomic study on molecular networks associated with EGFRm (+/-) status
Region
Japan

Condition
Condition Non-small cell lung cancer (NSCLC)
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To identify proteins expressed and their associated protein-protein interaction (PPI) networks / pathways significant to EGFR mutations positive and negative.
Basic objectives2 Others
Basic objectives -Others To attain information of molecular networks associated with EGFR(+/-) status of NSCLC patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of disease-related expressed proteins associated with the presence or absence of EGFR mutation and extraction of their molecular interaction networks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases which were diagnosed pathologically a primary lung adenocarcinoma and the presence or absence of EGFR mutation was clarified.
Eastern Cooperative Oncology Group (ECOG)PS: 0 to 2
Key exclusion criteria The case where patient's consent was withdrawn.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Saji
Organization St. Marianna University School of Medicine
Division name Chest Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Email h-nakamura@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Shimamura
Organization St. Marianna University School of Medicine
Division name Translational Medicine Informatics
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Homepage URL
Email shimamura@marianna-u.ac.jp

Sponsor
Institute Chest Surgery, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 聖マリアンナ医科大学        Dept. Translational Medicine
分子病態情報講座 (神奈川県)   Informatics, St Marianna U. School of Medicine 
(Kanagawa)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 10 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 Completed
Date of protocol fixation
2016 Year 12 Month 16 Day
Date of IRB
2017 Year 02 Month 24 Day
Anticipated trial start date
2017 Year 04 Month 10 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information Among cases that were pathologically confirmed as primary lung non - small cell lung cancer and were detected on the presence or absence of EGFR gene mutation, EGFR mutation positive 25 cases and negative 25 cases will be randomly taken. Furthermore, among the 25 positive EGFR mutations, when PD (progressive disease) and drug resistance were observed for the cases that administration of 1 / 2th generation EGFR-TKI, then tumor biopsies will be again obtained in order to perform further in-depth protein analysis.

Management information
Registered date
2017 Year 03 Month 31 Day
Last modified on
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030771

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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