UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	nagao@hp.pref.hyogo.jp

Sponsor
Institute	Hyogo Cancer Center
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	Hyogo Cancer Center IRB
Address	13-70Kitaoji-cho, Akashi-city
Tel	078-929-1151
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027795