UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053138 |
|---|---|
| Receipt number | R000060643 |
| Scientific Title | Validation study of incidence of thromboembolism in lung cancer patients |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/18 02:08:34 |
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Basic information
Public title
Validation study of incidence of thromboembolism in lung cancer patients
Acronym
Validation study of incidence of thromboembolism in lung cancer patients
Scientific Title
Validation study of incidence of thromboembolism in lung cancer patients
Scientific Title:Acronym
Validation study of incidence of thromboembolism in lung cancer patients
Region
| Japan |
Condition
Condition
Non-small cell lung cancer, small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the frequency of venous thromboembolism in lung cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Rising score calculated using the incidence of new venous thoromboembolism in 2 years
Key secondary outcomes
Over all survival
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
Pathologically diagonosed non-small cell or small cell lung cancer
ECOG PS 0-3
Age over 20 years old
Small cell lung cancer for which radical surgery, radiation therapy, or chemoradiotherapy is not possible (LD or ED)
Non-small cell lung cancer for which radical surgery, radiation therapy, or chemoradiotherapy is not possible (regardless of stage)
Reccurence of operation or concurrent chemoradiotherapy
Best supportive care patient
6 months or longer expected survival
Written informed consent
Key exclusion criteria
none
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Tsubata |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Isumo, Shimane
TEL
0853-20-2580
ytsubata@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoki |
| Middle name | |
| Last name | Tsuda |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Isumo, Shimane
TEL
0853-20-2580
Homepage URL
t.hirotoki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
89-1 Enya-cho, Isumo, 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
| 2023 | Year | 12 | Month | 18 | 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
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline items for this study (e.g., patient background, blood tests, imaging studies, etc.) will be collected after enrollment. For cases in which the onset of VTE is observed during the observation period, additional items (symptoms, blood tests, imaging tests, etc.) will be collected. At the end of the observation, the ECOG PS of the study subject, the presence or absence of the onset of thromboembolism during the observation period, and if so, the observation items at the time of the onset of VTE, and survival will be confirmed.
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060643
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
