A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06866964
Phase
PHASE2
Status
Recruiting
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Conditions

  • Germ Cell Tumor
  • Testicular Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-dose ASA — DRUG
    81 mg by mouth daily for 26 weeks

Study Details

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

Key Dates

Start date
Aug 28, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Low-dose aspirin (acetylsalicylic acid [ASA])
    ASA has been shown to reduce risk of VTE. It will be self-administered, a fixed dose of ASA (81 mg) by mouth daily for 26 weeks.

Primary Outcome Measure

Venous thromboembolism (VTE)-free [ Time Frame: 26 weeks after initiation of standard chemotherapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterCharlotteNorth Carolina28204
Margarita Dzhanumova
[email protected]
980-515-5300
Landon Brown, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Michael McCormack, MD
[email protected]
336-716-7975
Michael McCormack, MD (PRINCIPAL_INVESTIGATOR)
Aurora St. Luke's Medical Center MOBMilwaukeeWisconsin53215
Milanka Petrovic
[email protected]
414-649-5391
Antony Ruggeri, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By research site
Atrium Health Wake Forest Baptist Comprehensive Cancer Center· Charlotte, NCWake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NCAurora St. Luke's Medical Center MOB· Milwaukee, WI

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