Aspirin may shield cancer patients from deadly clots during chemo
NCT ID NCT06866964
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This study tests whether a daily low-dose aspirin can prevent dangerous blood clots in people with advanced germ cell tumors (including testicular cancer) who are receiving standard chemotherapy. About 35 participants will take aspirin alongside their chemo for 26 weeks. The goal is to see if fewer people develop clots compared to similar patients from past studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Exclusion Criteria: 1. Receiving chemotherapy in adjuvant setting 2. Prior VTE/PE 3. Currently taking anticoagulation or antiplatelet therapy. Non-steroidal anti-inflammatory drug (NSAID) use for pain is allowed 4. Prior indication for anticoagulation or anticoagulation contraindicated (e.g., active bleed or risk of bleeding, such as history of gastrointestinal ulcers) 5. Allergy to ASA
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITINGCharlotte, North Carolina, 28204, United States
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Aurora St. Luke's Medical Center MOB
RECRUITINGMilwaukee, Wisconsin, 53215, United States
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Wake Forest Baptist Comprehensive Cancer Center
RECRUITINGWinston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cancer diagnosis can shock the whole family: study maps who struggles most
- Can a faster chemo schedule beat tough testicular cancer?
- Hidden heart risks in testicular cancer survivors: a closer look at chemotherapy's long shadow
- Glowing dye could reveal hidden cancer spread in testicular tumors
- New chemo cocktail targets Hard-to-Treat testicular cancer
- High-Dose chemo with stem cell transplant tested against standard therapy for tough germ cell cancers