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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026886
Receipt No. R000029181
Scientific Title A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism in gynecological cancer patients.
Date of disclosure of the study information 2017/04/06
Last modified on 2019/02/22

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Basic information
Public title A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism
in gynecological cancer patients.
Acronym GOTIC-VTE trial/GOTIC-015
Scientific Title A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism
in gynecological cancer patients.
Scientific Title:Acronym GOTIC-VTE trial/GOTIC-015
Region
Japan

Condition
Condition gynecological cancer
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is intended to clarify the actual condition of venous thromboembolism (VTE) in gynecological cancer patients and verify the superiority of perioperative long-term anticoagulation therapy for asymptomatic VTE patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [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
Key secondary outcomes [Registry part]
-Incidence of brain infarction/ systemic embolism
-Survival
-VTE related mortality rate and bleeding related mortality rate
-Brain infarction related mortality rate and systemic embolism related mortality rate

[Interventional part]
1) Incidence of symptomatic VTE (VTE, DVT, proximal DVT, distal DVT) for 28 days after surgery.
2) Incidence of bleeding events (MB, CRNMB, MB or CRNMB) for 28 days after surgery.
3) Incidence of HIT for 28 days after surgery.
4) VTE related mortality rate and bleeding related mortality rate for 28 days after surgery.
5) Incidence of symptomatic VTE (VTE, PE, DVT, proximal DVT, distal DVT) for 6 months after surgery.
6) Incidence of bleeding events (MB, CRNMB, MB or CRNMB) for 6 months after surgery.
7) Incidence of HIT for 6 months after surgery.
8) VTE related mortality rate and bleeding related mortality rate for 6 months after surgery.
9) survival
1.Overall survival: Period from registration to all-cause deaths.
2.Symptomatic VTE event-free survival: Period from registration to occurrence of symptomatic VTE.

10) Incidence of any adverse events that can't be denied relationship with the study drug or the protocol treatment from the protocol treatment start day to 30th day after the end of the protocol treatment
11) Incidence of any adverse events that can't be denied relationship with the study drug or the protocol treatment from the protocol treatment start day to 6 months after the end of the protocol treatment.


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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Perform anticoagulation therapy for 4 weeks postoperatively by switching from UFH to LMWH, Edoxaban for gynecological cancer patients who have founded asymptomatic VTE before surgery.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria [Registry part]
(1) Over 20 years old at written informed consent.
(2) Diagnosed with endmetrial cancer,cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer(both initial and/or recurrence, but if final pathological diagnosis is benign tumors or borderline malignant tumors, it is excluded from the analysis.).
(3) Planned to undergo drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or surgery. For recurrence cases, patients who received drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or underwent surgery at initial occurrence can be enrolled.
(4) Carried out VTE screening (ultrasonography of the lower extremity veins (results of lower extremity contrast-enhanced CT within clinical practice is available)) within 2 months before enrollment (the same day of the week of 8 weeks before the registration date is available) and before the cancer treatment. If the D-dimer value within 2 months prior to registration is less than 1.2 microg/ml, it is acceptable even if VTE screening is not done (Treat as VTE not exist).

[Interventional part]
(1) Age at the time of written informed consent: 20 or older, 75 or younger.
(2) Initial patients diagnosed with endometrial carcinoma or cervical carcinoma (exclude carcinoma in situ), assumed to have epithelial ovarian, Fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis.
(3) Patients who founded DVT by lower extremities venous ultrasound or Lower Extremity contrast-enhanced CT within 2 months before enrollment (the same day of the week of 8 weeks before the registration date is available) and before the cancer treatment, or PE by thoracic contrast-enhanced CT.
(4) Patients who have searched for both DVT and PE.
(5) Patients without symptoms associated with VTE at the time of registration.


Key exclusion criteria [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).

Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Fujiwara
Organization Jichi Medical University
Division name Depertment of obsterics and gynecology
Zip code
Address 3311-1 Yakushiji Shimotsuke city Tochigi
TEL 0285-58-7376
Email fujiwara@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuko Mouri
Organization Kanagawa Institute of Industrial Science and Technology
Division name Global Health Research Coordinating Center
Zip code
Address KSP East 3F 309, 3-2-1 Sakado Takatsu-ku Kawasaki
TEL 044-850-1731
Homepage URL
Email gyn-vte@newkast.or.jp

Sponsor
Institute GOTIC
Institute
Department

Funding Source
Organization Medical Science Department
Daiichi Sankyo Company, Limited.
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 jRCTs031180124
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 06 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
2017 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 06 Day
Last modified on
2019 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029181

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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