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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013495
Receipt No. 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

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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
Email 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
Email siwata@chiba-cc.jp

Sponsor
Institute Japanese Musculoskeletal Oncology Group (JMOG)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015763

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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