UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013495 |
|---|---|
| Receipt number | R000015763 |
| Scientific Title | A prospective observational study of venous thromboembolism in patients with bone and soft tissue sarcomas in Japan. |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2019/09/29 13:09:27 |
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Basic information
Public title
A prospective observational study of venous thromboembolism in patients with bone and soft tissue sarcomas in Japan.
Acronym
Venous thromboembolism cohort study for sarcoma (VTECS)
Scientific Title
A prospective observational study of venous thromboembolism in patients with bone and soft tissue sarcomas in Japan.
Scientific Title:Acronym
Venous thromboembolism cohort study for sarcoma (VTECS)
Region
| Japan |
Condition
Condition
Bone and soft tissue sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of venous thromboembolism (VTE) and the risk factors for VTE in patients with bone and soft tissue sarcoma in Japan.
Basic objectives2
Others
Basic objectives -Others
Incidence and risk factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence rate of symptomatic VTE at 6 months after the surgery.
Key secondary outcomes
The incidence rate of symptomatic VTE at 7,14,28 days after the surgery.
Relationship between the candidate risk factors and the incidence rate of symptomatic VTE.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically diagnosed as bone and soft tissue sarcoma
2) planned to underwent surgical excision at JMOG participants institutes
3) 18 years old or more
4) obtained written informed consent
Key exclusion criteria
1) diagnosed as metastatic or benign musculoskeletal tumor
2) past history of bleeding disorder (deficiencies of protein C, S, AT-III, anti-phospholipid antibody syndrome, and hemophilia)
3) having active infection
4) underwent surgical intervention within 6 months
5) past history of VTE
6) receiving anticoagulant therapy
7) other exclusionary comorbidity
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Yonemoto |
Organization
Chiba Cancer Center
Division name
Division of Orthopedic Surgery
Zip code
2608717
Address
666-2 Nitona-cho, Chuo-ku, Chiba
TEL
043-264-5431
tyonemot@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Iwata |
Organization
Chiba Cancer Center
Division name
Division of Orthopedic Surgery
Zip code
2608717
Address
666-2 Nitona-cho, Chuo-ku, Chiba
TEL
043-264-5431
Homepage URL
siwata@chiba-cc.jp
Sponsor or person
Institute
Japanese Musculoskeletal Oncology Group (JMOG)
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
Institutional Review Board, Chiba Cancer Center
Address
666-2 Nitona-cho, Chuo-ku, Chiba
Tel
043-264-5431
hnagase@chiba-cc.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
千葉県がんセンター（千葉）を含む約30施設
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015763
| 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 |
