UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038392 |
|---|---|
| Receipt number | R000043690 |
| Scientific Title | Incidence and clinical outcome of venous thromboembolism in adults with cancer |
| Date of disclosure of the study information | 2019/10/25 |
| Last modified on | 2021/03/01 20:09:23 |
* 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
Incidence and clinical outcome of venous thromboembolism in adults with cancer
Acronym
Incidence and clinical outcome of venous thromboembolism in adults with cancer
Scientific Title
Incidence and clinical outcome of venous thromboembolism in adults with cancer
Scientific Title:Acronym
Incidence and clinical outcome of venous thromboembolism in adults with cancer
Region
| Japan |
Condition
Condition
Deep vein thrombosis
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate deep vein thrombosis screening in Hyogo Cancer Center, we investigate the lower extremity vessel ultrasonography examination performed in 2018 and estimate the incidence of positive study.
Basic objectives2
Others
Basic objectives -Others
We study the difference of deep vein thrombosis incidence between medical and surgical cancer patinets
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of deep vein thrombosis image in ultrasonography examination
Key secondary outcomes
Time dependent change of ultrasonography findings
D-dimer value
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients examined by lower extremity ultrasonography to rule out deep vein thrombosis
Key exclusion criteria
Patients not aimed to examine lower extremity venous thrombosis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Katoh |
Organization
Hyogo Cancer Center
Division name
Department of anesthesiology
Zip code
6730021
Address
13-70 KitaOji Akashi
TEL
0789291151
whoami@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Kaoth |
Organization
Hyogo Cancer Center
Division name
Department of anesthesiology
Zip code
6730021
Address
13-70 KitaOji Akashi
TEL
0789291151
Homepage URL
whoami@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
self dependent
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
Hyogo Cancer Center
Address
13-70 KitaOji Akashi
Tel
0789291151
whoami@hp.pref.hyogo.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 25 | 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
1031
Results
Preoperative screening detected thromboembolism(TE) in 83 of 408 (26%) patients. Thirty three of 249 (15%) patients were diagnosed as TE by postoperative screening. Total incidents of perioperative TE were 116 of 657 (20%) screenings. Further, 102 of 562 patients for non-surgical treatment were detected TE. Overall incidence of TE in adult cancer patients was 20% of 1219 tests. TE of perioperative patients showed earlier tendency of TE disapprarance than that of non-surgical patients.
Results date posted
| 2019 | Year | 10 | Month | 28 | Day |
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
| 2019 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 21 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 28 | Day |
Other
Other related information
Data collection finished
Management information
Registered date
| 2019 | Year | 10 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043690
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
