A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy (NCT06866964)

🧪 Interventions in This Study

• Low-dose ASA (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Written informed consent and HIPAA authorization for release of personal health information
2. Age ≥ 18 years and ≤ 70 years at the time of consent
3. Histological confirmation of stage IS or IIA or higher testicular or germ cell cancer. Primary mediastinal and retroperitoneal GCT are allowed. Seminoma and non-seminoma histologies are allowed.
4. Performance Status (PS) of ECOG 0-2 at the time of enrollment
5. At least one of the following "high risk" of VTE features: a. Stage IIC or III or higher per AJCC 8th edition criteria i. Stage IIC - any pT/TX, N3, M0, S0-1 ii. Stage III - any pT/TX, any N, M1, SX iii. Stage IIIA - any pT/TX, any N, M1a, S0-1 iv. Stage IIIB - any pT/TX, N1-3, M0, S2 or any pT/TX, any N, M1a, S2 v. Stage IIIC - any pT/TX, N1-3, M0, S3 or any pT/TX, any N, M1a, S3 or any pT/TX, any N, M1b, any S Serum marker (S category) S criteria SX Marker studies not available or not performed S0 Marker study levels within normal limits S1 LDH \< 1.5 x normal and hCG \< 5000 IU/L and AFP \<1000 ng/mL S2 LDH 1.5 to 10 x normal or hCG 5000 to 50,000 IU/L or AFP 1000 to 10,000 ng/mL S3 LDH \>10 x normal or hCG \>50,000 IU/L or AFP \>10,000 ng/mL b. Intermediate or poor risk by IGCCCG criteria i. Intermediate risk - testis/retroperitoneal primary and no non pulmonary visceral metastases plus at least one of the following markers: AFP \> 1,000 ng/mL to ≤ 10,000 ng/mL, beta-hCG \> 5,000 IU/L and ≤ 50,000 IU/L, LDH \>1.5 x normal and ≤ 10 x normal ii. Poor risk - mediastinal primary or non-pulmonary visceral metastases plus at least one of the following markers: AFP \> 10,000 ng/mL, beta- hCG \> 50,000 IU/L, LDH \> 10 x normal c. Khorana score of 2 or higher i. +1 point for testicular/germ cell cancer (All patients will receive +1 for their testicular/germ cell cancer diagnosis. Thus, a patient with any other Khorana characteristic \[ii-v\] will meet this inclusion criteria.) ii. +1 point for platelet ≥350 x 10\^9/L iii. +1 point for hemoglobin \<10 g/dL iv. +1 point for leukocyte count \>11 x 10\^9/L v. +1 point for BMI \>35 kg/m\^2
6. Planning or recently started 3-4 cycles of standard of care front-line cisplatin-based chemotherapy (bleomycin, etoposide, and platinum \[BEP\], etoposide and cisplatin \[EP\], or etoposide, ifosfamide, and cisplatin \[VIP\]). Note: ASA should be initiated no later than 2 weeks after initiation of standard front-line chemotherapy.
7. As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
8. Ability to swallow oral medications

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Charlotte, North Carolina
• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina
• Aurora St. Luke's Medical Center MOB — Milwaukee, Wisconsin

📞 Contact the Study Coordinator

Phone: (980) 515-5300

Email: margarita.dzhanumova@advocatehealth.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: +1 point for testicular/germ cell cancer (All patients will receive +1 for their testicular/germ cell cancer diagnosis.

More studies in Germ Cell Tumor

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• Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours — New York, New York
• Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors — Basking Ridge, New Jersey
• A Study of miRNA 371 in Patients With Germ Cell Tumors — Gilbert, Arizona
• Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT — Indianapolis, Indiana

Explore by condition: All Germ Cell Tumor clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.