UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032248 |
|---|---|
| Receipt number | 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 08:33:26 |
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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
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
tomowithkk@gmail.com
Sponsor or person
Institute
Sendai Kosei Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036704
