UMIN-CTR Clinical Trial

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Key exclusion criteria	The case where patient's consent was withdrawn.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/icdr_e/ctr_view.cgi?recptno=R000030771