[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582719":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":84,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":32,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-dose aspirin (acetylsalicylic acid [ASA])","EXPERIMENTAL","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.",[13],"Drug: Low-dose ASA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Low-dose ASA","81 mg by mouth daily for 26 weeks",[9],[21],"aspirin",[23],{"name":24,"affiliation":25,"role":26},"Landon Brown, MD","Atrium Health Wake Forest Baptist Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Margarita Dzhanumova","CONTACT","980-515-5300",null,"margarita.dzhanumova@advocatehealth.org",[35,51,66],{"facility":25,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Charlotte","North Carolina","28204","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-80.84313,35.22709,{"lat":46,"lon":45},[49,50],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":24,"role":26,"phone":32,"phoneExt":32,"email":32},{"facility":52,"status":36,"city":53,"state":38,"zip":54,"country":40,"countryCode":41,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Wake Forest Baptist Comprehensive Cancer Center","Winston-Salem","27157",{"type":43,"coordinates":56},[57,58],-80.24422,36.09986,{"lat":58,"lon":57},[61,65],{"name":62,"role":30,"phone":63,"phoneExt":32,"email":64},"Michael McCormack, MD","336-716-7975","mmccorma@wakehealth.edu",{"name":62,"role":26,"phone":32,"phoneExt":32,"email":32},{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":40,"countryCode":41,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Aurora St. Luke's Medical Center MOB","NOT_YET_RECRUITING","Milwaukee","Wisconsin","53215",{"type":43,"coordinates":73},[74,75],-87.90647,43.0389,{"lat":75,"lon":74},[78,82],{"name":79,"role":30,"phone":80,"phoneExt":32,"email":81},"Milanka Petrovic","414-649-5391","milanka.petrovic@aah.org",{"name":83,"role":26,"phone":32,"phoneExt":32,"email":32},"Antony Ruggeri, MD",{"type":85,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[87],{"name":88,"class":6},"Atrium Health Wake Forest Baptist","100582719","phase-2-a-single-arm-phase-ii-clinical-trial-of-aspirin-to-prevent-venous-thromboembolism-in-patients-with-advanced-germ-cell-tumors-receiving-chemotherapy-100582719",false,"NCT06866964","A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy","ASPIRE","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information\n2. Age ≥ 18 years and ≤ 70 years at the time of consent\n3. 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.\n4. Performance Status (PS) of ECOG 0-2 at the time of enrollment\n5. At least one of the following \"high risk\" of VTE features:\n\n   a. Stage IIC or III or higher per AJCC 8th edition criteria i. Stage IIC - any pT\u002FTX, N3, M0, S0-1 ii. Stage III - any pT\u002FTX, any N, M1, SX iii. Stage IIIA - any pT\u002FTX, any N, M1a, S0-1 iv. Stage IIIB - any pT\u002FTX, N1-3, M0, S2 or any pT\u002FTX, any N, M1a, S2 v. Stage IIIC - any pT\u002FTX, N1-3, M0, S3 or any pT\u002FTX, any N, M1a, S3 or any pT\u002FTX, 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 \\\u003C 1.5 x normal and hCG \\\u003C 5000 IU\u002FL and AFP \\\u003C1000 ng\u002FmL S2 LDH 1.5 to 10 x normal or hCG 5000 to 50,000 IU\u002FL or AFP 1000 to 10,000 ng\u002FmL S3 LDH \\>10 x normal or hCG \\>50,000 IU\u002FL or AFP \\>10,000 ng\u002FmL\n\n   b. Intermediate or poor risk by IGCCCG criteria i. Intermediate risk - testis\u002Fretroperitoneal primary and no non pulmonary visceral metastases plus at least one of the following markers: AFP \\> 1,000 ng\u002FmL to ≤ 10,000 ng\u002FmL, beta-hCG \\> 5,000 IU\u002FL and ≤ 50,000 IU\u002FL, 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\u002FmL, beta- hCG \\> 50,000 IU\u002FL, LDH \\> 10 x normal c. Khorana score of 2 or higher i. +1 point for testicular\u002Fgerm cell cancer (All patients will receive +1 for their testicular\u002Fgerm 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\u002FL iii. +1 point for hemoglobin \\\u003C10 g\u002FdL iv. +1 point for leukocyte count \\>11 x 10\\^9\u002FL v. +1 point for BMI \\>35 kg\u002Fm\\^2\n6. 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.\n7. As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study\n8. Ability to swallow oral medications\n\nExclusion Criteria:\n\n1. Receiving chemotherapy in adjuvant setting\n2. Prior VTE\u002FPE\n3. Currently taking anticoagulation or antiplatelet therapy. Non-steroidal anti-inflammatory drug (NSAID) use for pain is allowed\n4. Prior indication for anticoagulation or anticoagulation contraindicated (e.g., active bleed or risk of bleeding, such as history of gastrointestinal ulcers)\n5. Allergy to ASA","ALL","18 Years","70 Years",{"count":100,"type":101},35,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","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",[107,108],"Germ Cell Tumor","Testicular Cancer",[110,111],"cancer","Venous thromboembolism","2026-01-30",{"date":114,"type":115},"2026-02-02","ACTUAL",{"date":117,"type":115},"2025-08-28",{"date":119,"type":101},"2031-01",{"name":5,"class":6},3]