UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002894
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yyoshim@shinshu-u.ac.jp

Sponsor
Institute Dept. of orthopaedic surgery,Shinshu university school of medicine
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.