Actively Recruiting
A Single-Arm Phase II Trial of Aspirin to Prevent Venous Thromboembolism in Advanced Germ Cell Tumors Receiving Chemotherapy
Led by Wake Forest University Health Sciences · Updated on 2026-02-02
35
Participants Needed
3
Research Sites
74 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
A
Atrium Health Wake Forest Baptist
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the rate of venous thromboembolism (VTE) over six months in participants with advanced germ cell cancer who are at high risk of VTE. The study focuses on those receiving standard cisplatin-based chemotherapy combined with low-dose acetylsalicylic acid (ASA). This Phase II, single-arm trial compares results to historical data to understand how well ASA may prevent VTE in this specific population. Participants will self-administer a fixed daily dose of 81 mg ASA by mouth for 26 weeks alongside their chemotherapy. The study has two stages: initially, 13 participants will be enrolled, and if most do not experience VTE during the first 26 weeks, an additional 18 participants will join. If a participant develops VTE, they will stop ASA and start standard anticoagulation treatment. The trial is initially conducted at a single center with plans to add more sites later. During the study, participants will be closely monitored for VTE events and bleeding complications. Researchers will assess VTE occurrence at 26 weeks, and secondary outcomes include major and non-major bleeding events, relapse-free survival, and overall survival up to two years after starting chemotherapy. Participants will provide their own ASA supply and are expected to comply with daily medication and study procedures throughout the trial duration.
CONDITIONS
Brief Title
A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization for personal health information release
- Age 18 to 70 years at the time of consent
- Histological confirmation of stage IS or IIA or higher testicular or germ cell cancer
- Performance Status of ECOG 0-2
- At least one high-risk feature for VTE, including advanced stage or elevated tumor markers, intermediate or poor risk by IGCCCG criteria, or a Khorana score of 2 or higher
- Planning or recently started 3-4 cycles of standard cisplatin-based chemotherapy
- Ability to understand and comply with study procedures
- Ability to swallow oral medications
You will not qualify if you...
- Receiving chemotherapy as adjuvant treatment
- Prior venous thromboembolism or pulmonary embolism
- Currently taking anticoagulation or antiplatelet therapy (NSAIDs for pain allowed)
- Prior indication for anticoagulation or contraindications due to bleeding risk
- Allergy to aspirin
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants self-administer a fixed dose of low-dose aspirin (81 mg) by mouth daily for 26 weeks while receiving standard cisplatin-based chemotherapy.
Weekly visits for up to 26 weeks
Trial Site Locations
Total: 3 locations
1
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
3
Aurora St. Luke's Medical Center MOB
Milwaukee, Wisconsin, United States, 53215
Not Yet Recruiting
Research Team
M
Margarita Dzhanumova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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