UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002894 |
|---|---|
| Receipt number | R000003522 |
| Scientific Title | Screening for deep vein thrombosis after surgery of muskuloskeletal tumors arising from lower extremities. |
| Date of disclosure of the study information | 2010/01/04 |
| Last modified on | 2014/12/19 17:38:11 |
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Basic information
Public title
Screening for deep vein thrombosis after surgery of muskuloskeletal tumors arising from lower extremities.
Acronym
Screening for deep vein thrombosis after surgery of muskuloskeletal tumors.
Scientific Title
Screening for deep vein thrombosis after surgery of muskuloskeletal tumors arising from lower extremities.
Scientific Title:Acronym
Screening for deep vein thrombosis after surgery of muskuloskeletal tumors.
Region
| Japan |
Condition
Condition
musculoskeletal tumors arising from lower extremities.
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of usefullness for soluble fibrin and D-dimer as markers for early detection of venous thromboembolism following surgery of musculosleletal tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Values of soulble fibrin before surgery and day1,3,7 after surgery.
Values of D-dimer before surgery and day1,7,14,21 after surgery.
Key secondary outcomes
Evaluation of ultrasonography for deep venous thromboembolism before surgery and day1,3,7,14 after surgery.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Evaluation for deep venous thromboembolism of lower extremities by ultrasonography before surgery and at day1,3,7,14 after surgry.
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with musculoskeletal sarcoma of lower extremity or with benign musculoskeletal tumor over 10cm in deep localization.
Key exclusion criteria
Patients less than 12 years old.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Yoshimura |
Organization
Shinshu university school of medicine
Division name
Dept. of orthopaedic surgery
Zip code
Address
3-1-1 Asahi, Matsumoto,Nagano prefecture
TEL
0263-37-2659
yyoshim@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Yoshimura |
Organization
Shinshu university school of medicine
Division name
Dept. of orthopaedic surgery
Zip code
Address
3-1-1 Asahi, Matsumoto,Nagano prefecture
TEL
0263-37-2659
Homepage URL
yyoshim@shinshu-u.ac.jp
Sponsor or person
Institute
Dept. of orthopaedic surgery,Shinshu university school 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
Address
Tel
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
信州大学病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 14 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003522
