UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mathematical Modeling-based Medication for Minimizing Malignant evolution of Lung Cancer
Title of the study (Brief title)	M5-LC
Region	Japan

Condition
Condition	EGFR mutation-positive lung adenocarcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To understand the dynamics of lung cancer evolution, by means of longitudinal ctDNA monitoring and simulation-based approach, in the course of EGFR-TKI therapy in patients with EGFR mutation-positive lung cancer.
Basic objectives2	Others
Basic objectives -Others	To verify appropriate therapeutic strategy and therapeutic sequence in the management of patients with EGFR mutation-positive lung cancer.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Mathematical modeling to understand the dynamics of lung cancer evolution.
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	1) Estimated life expectancy > 3 months 2) Written informed consent for participation in this study is obtained 3) Patients with stage IV, recurrent or Stage IIIB/C, without any indication for radical radiation therapy, lung adenocarcinoma who received no prior chemotherapy. 4) Lung adenocarcinoma that is histologically or cytologically diagnosed as well as confirmed as EGFR mutation positive by the validated methods for the detection of EGFR mutations. 5) Patients who are judged suitable for Afatinib therapy by investigators. 6) Measurable disease as defined by RECIST guideline (ver. 1.1)
Key exclusion criteria	1) History of any type of malignancy within the past 5 years (including carcinoma in situ). 2) History of organ transplantation (including hematopoietic stem cell transplantation) 3) Major surgery within one month prior to the first blood sampling in this study. 4) Radiotherapy for brain metastatic or other locally advanced lesions within two weeks prior to the first blood sampling in this study. 5) Concomitant presence of distinct types of lung cancer is confirmed: - Patients with histologically distinct types of lung cancer, including lung squamous cell carcinoma and small cell lung cancer, will be excluded. - Patients with distinct lung adenocarcinomas harboring ALK translocation or ROS1 translocation will be excluded.
Target sample size	5

Research contact person
Name of lead principal investigator	Shunichi Sugawara
Organization	Sendai Kosei Hospital
Division name	Respiratory medicine
Address	4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan
TEL	81-22-222-6181
Email	swara357@sendai-kousei-hospital.jp

Public contact
Name of contact person	Tomoiki Aiba
Organization	Sendai Kosei Hospital
Division name	Respiratory medicine
Address	4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan
TEL	81-22-222-6181
Homepage URL
Email	tomowithkk@gmail.com

Sponsor
Institute	Sendai Kosei Hospital
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Health Medical Computational Science, Health Intelligence Center, The Institute of Medical Science, The University of Tokyo Genomedia Inc.
Name of secondary funｄer(s)

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	2018 Year 04 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 18 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Recruitment of study subjects: Among newly-treated patients as EGFR mutation-positive lung adenocarcinoma in Sendai Kosei hospital from July 2018 to March 2019, those who meet the inclusion and exclusion criteria can be the study subjects.

Management information
Registered date	2018 Year 04 Month 14 Day
Last modified on	2018 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036704