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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032248
Receipt No. R000036704
Scientific Title Mathematical Modeling-based Medication for Minimizing Malignant evolution of Lung Cancer
Date of disclosure of the study information 2018/04/20
Last modified on 2018/10/25

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Basic information
Public title Mathematical Modeling-based Medication for Minimizing Malignant evolution of Lung Cancer
Acronym M5-LC
Scientific Title Mathematical Modeling-based Medication for Minimizing Malignant evolution of Lung Cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Shunichi Sugawara
Organization Sendai Kosei Hospital
Division name Respiratory medicine
Zip code
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
1st name
Middle name
Last name Tomoiki Aiba
Organization Sendai Kosei Hospital
Division name Respiratory medicine
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036704

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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