UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024141 |
|---|---|
| Receipt number | R000027795 |
| Scientific Title | The diagnosis of asymptomatic deep venous thrombosis by D-dimer in patients with recurrent gynecologic cancer. |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2021/03/28 18:17:32 |
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Basic information
Public title
The diagnosis of asymptomatic deep venous thrombosis by D-dimer in patients with recurrent gynecologic cancer.
Acronym
D-diRec study
Scientific Title
The diagnosis of asymptomatic deep venous thrombosis by D-dimer in patients with recurrent gynecologic cancer.
Scientific Title:Acronym
D-diRec study
Region
| Japan |
Condition
Condition
Ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the application of periodic measurement of D-dimer to detect asymptomatic DVT in posttreatment patients with epithelial ovarian cancer.
Basic objectives2
Others
Basic objectives -Others
To assess the prevalence rate of DVT in recurrent ovarian cancer.
To assess the efficacy of D-dimer, CRP, or blood test to detect DVT.
To assess the efficacy of D-dimer to detect recurrent ovarian cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
NPV,PPV,sensitivity,and specificity of D-dimer value to detect DVT
Key secondary outcomes
The prevalence rate of DVT in recurrent ovarian cancer.
NPV,PPV,sensitivity,and specificity and specificity of white blood cell count, neutrophil count, platelet count, and serum CRP value to detect DVT.
Tendency of D-dimer before clinical recurrence.
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
| Other |
Interventions/Control_1
Measurement of D-dimer, blood cell count, neutrophil count, platelet count, serum CRP value.
Ultra-sonography of deep vein of leg (if D-dimer>1.5mg/mL )
Chest CT scan (if pulmonary thromboembolic disease was suspected)
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
Female
Key inclusion criteria
Posttreatment women with epithelial ovarian cancer.
Key exclusion criteria
Patients with recurrent ovarian cancer.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Nagao |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
673-8558
Address
13-70Kitaoji-cho, Akashi-city
TEL
078-929-1151
nagao@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Nagao |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
673-8558
Address
13-70Kitaoji-cho, Akashi-city
TEL
078-929-1151
Homepage URL
nagao@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
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
Hyogo Cancer Center IRB
Address
13-70Kitaoji-cho, Akashi-city
Tel
078-929-1151
rinsyoshikenkanri3@hyogo-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 23 | 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
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027795
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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