A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism in gynecological cancer patients.
- Conditions
- gynecological cancer
- Registration Number
- JPRN-UMIN000026886
- Lead Sponsor
- GOTIC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 1000
Not provided
[Registry part] (1) A patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with carcinoma in situ and intramucosal carcinoma are eligible for the study). (2) A patient who is inappropriate as a subject of the study judged by investigator. [Interventional part] (1) Body weigh less than 40 kg. (2) APTT value before the anticoagulation therapy starts prolonged more than 40 seconds. (3) A patient who have not scheduled to undergo surgery during the initial treatment period. (4) A patient who have already received anticoagulant therapy due to underlying diseases before diagnosing VTE ( A patient who have started some anticoagulant therapy after diagnosing VTE is available). (5) A patient who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with carcinoma in situ and intramucosal carcinoma are eligible for the study). (6) A patient with the following complications that may affect the conduct of this study and the evaluation of this study drug. 1) Bleeding lesion not due to gynecological cancer (including history of cerebrovascular disorder and subarachnoid hemorrhage within 6 months before registration) . 2) Uncontrolled hypertension. 3) Uncontrolled diabetes. 4) Suspicious of acute infective endocarditis. 5) Arterial embolism other than PE (including history).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Registry part] 1) Base line -Frequency of intercurrent of VTE at the time of VTE screening. 2) Observation period (one year) -Incidence of symptomaticVTE -Incidence of bleeding events [Interventional part] -Incidence of symptomatic PE during 28 days after surgery
- Secondary Outcome Measures
Name Time Method