UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046863 |
|---|---|
| Receipt number | R000053458 |
| Scientific Title | Preliminary study to clarify the mechanism of cancer-related thromboembolism in patients with EGFR mutation positive lung cancer |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2022/02/08 13:14:27 |
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Basic information
Public title
Preliminary study to clarify the mechanism of cancer-related thromboembolism in patients with EGFR mutation positive lung cancer
Acronym
Basic research of Rising-VTE
Scientific Title
Preliminary study to clarify the mechanism of cancer-related thromboembolism in patients with EGFR mutation positive lung cancer
Scientific Title:Acronym
Basic research of Rising-VTE
Region
| Japan |
Condition
Condition
EGFR mutation positive non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the mechanism of cancer-related thromboembolism in patients with EGFR gene mutation-positive non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
Investigate the relationship between lung cancer driver gene mutations and thromboembolism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive measurement of coagulation / fibrinolytic factors in EGFR mutation-positive non-small cell lung cancer
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
EGFR positive non-small cell lung cancer
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Tsubata |
Organization
Shimane University Hospital
Division name
Medical Oncology and Respiratory Medicine
Zip code
693-8501
Address
Enya-cho 89-1, Izumo, Shimane
TEL
0853-20-2580
ytsubata@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Kawakado |
Organization
Shimane University Hospital
Division name
Medical Oncology and Respiratory Medicine
Zip code
693-8501
Address
Enya-cho 89-1, Izumo, Shimane
TEL
0853-20-2580
Homepage URL
keita.kawakado1112@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
Enya-cho 89-1, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
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
| 2022 | Year | 02 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no available
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053458
