UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015243 |
|---|---|
| Receipt number | R000017678 |
| Scientific Title | Venous thromboembolism in Shizuoka Observational Study |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2020/04/27 09:25:03 |
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Basic information
Public title
Venous thromboembolism in Shizuoka Observational Study
Acronym
VISUAL Study
Scientific Title
Venous thromboembolism in Shizuoka Observational Study
Scientific Title:Acronym
VISUAL Study
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the frequency of venous thromboembolism in patients with sold tumor, who will receive chemotherapy
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of venous thromboembolism for 24 weeks
Key secondary outcomes
The incidence of venous thromboembolism for 24 weeks by primary cancer site, The incidence of venous thromboembolism (at enrollment, 12 week, 24 week), the incidence of symptomatic venous thromboembolism for 24 weeks, The incidence of pulmonary thromboembolism, treatment of venous thromboembolism
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) Patients with metastatic or locally advanced solid tumor
2) Patients will receive chemotherapy during 4 weeks
3) Aged 20 or more
4) Performance status (ECOG) of 0-2
5) Written informed consent
Key exclusion criteria
1) Patients cannnot receive an iodinated contrast
2) Congenital coagulation factor deficiencies
3) Venous thromboembolism diagnosed 4 weeks before enrollment
4) Receivng anticoagulant
5) Patients cannnot receive venous ultrasound
6) Pregnant or lactating women or women of childbearing potential
7) Psychiatric disease
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Shizuoka Cancer Center
Division name
Devision of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
TEL
055-989-5222
t.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kenmotsu |
Organization
Shizuoka Cancer Center
Division name
Devision of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
TEL
055-989-5222
Homepage URL
h.kenmotsu@scchr.jp
Sponsor or person
Institute
Pharma Valley Center , Shizuoka Industrial Foundation
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center , Shizuoka Industrial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.
Tel
055-989-5222
tansaku_office@scchr.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
磐田市立総合病院（静岡県）、静岡県立総合病院（静岡県）、静岡市立静岡病院（静岡県）、順天堂大学医学部附属静岡病院（静岡県）、聖隷浜松病院（静岡県）、聖隷三方原病院（静岡県）、沼津市立病院（静岡県）、浜松医療センター（静岡県）、藤枝市立総合病院（静岡県）、静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 24 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Venous ultrasound and enhanced computed tmography were carried out at enrollment, 12 and 24 week after enrollment.
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017678
| Research Plan | |
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| 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 |
