Actively Recruiting
A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy
Led by Wake Forest University Health Sciences · Updated on 2026-02-02
35
Participants Needed
3
Research Sites
278 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
The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls
CONDITIONS
Official 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 release of personal health information
- Age 18 to 70 years at the time of consent
- Histological confirmation of stage IS or IIA or higher testicular or germ cell cancer, including primary mediastinal and retroperitoneal germ cell tumors; seminoma and non-seminoma types allowed
- Performance status of ECOG 0-2 at enrollment
- At least one high-risk feature for VTE: stage IIC or III or higher by AJCC 8th edition, intermediate or poor risk by IGCCCG criteria, or Khorana score of 2 or higher
- Planning or recently started 3-4 cycles of front-line cisplatin-based chemotherapy (BEP, EP, or VIP); aspirin must start no later than 2 weeks after chemotherapy begins
- Ability to understand and comply with study procedures
- Ability to swallow oral medications
You will not qualify if you...
- Receiving chemotherapy in an adjuvant setting
- History of prior venous thromboembolism or pulmonary embolism
- Currently taking anticoagulation or antiplatelet therapy (NSAIDs allowed for pain)
- Prior need for anticoagulation or contraindication to anticoagulation such as active bleeding or bleeding risk (e.g., gastrointestinal ulcers)
- Allergy to aspirin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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