[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06866964":3,"trial-entities:NCT06866964":122,"trial-summary:NCT06866964":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":116,"overall_officials":118,"references":120,"see_also_links":121},"NCT06866964","IRB00126906","A Single-arm, Phase II Clinical Trial of ASPIRin to prEvent Venous Thromboembolism in Patients With Advanced Germ Cell Tumors Receiving Chemotherapy","RECRUITING","2031-01","2026-07","2026-07-24","2025-08-28","Wake Forest University Health Sciences","OTHER",true,"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","This is a single-arm, two-stage, Phase II study designed to evaluate the 6-month 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 ASA as compared to relevant historical controls. Stage 1 will consist of 13 participants. If at least 9 of those 13 do not experience a VTE event during the first 26 weeks on the ASA, Stage 2 will be activated. Stage 2 will enroll an additional 18 participants for a total of 31. Participants will provide their own supply of ASA. Participants will self-administer a fixed dose of ASA (81 mg) by mouth daily for 26 weeks. Participants who experience the primary endpoint of VTE will stop ASA and start standard of care anticoagulation at the direction of the treating investigator. This study will initially open as a single center study at Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC) and additional investigational site(s) may be added following activation at the lead site.",[18,19],"Germ Cell Tumor","Testicular Cancer",[21,22],"cancer","Venous thromboembolism","INTERVENTIONAL","PREVENTION",[26],"PHASE2",{"count":28,"type":29},35,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DRUG","Low-dose ASA","81 mg by mouth daily for 26 weeks",[36],"Low-dose aspirin (acetylsalicylic acid [ASA])",[38],"aspirin",[40],{"measure":41,"description":42,"timeFrame":43},"Venous thromboembolism (VTE)-free","A binary variable indicating whether the participant had zero VTE events within 26 weeks of initiation of standard chemotherapy. VTE events include objectively confirmed symptomatic or asymptomatic proximal deep-vein thrombosis in a lower limb, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, symptomatic or incidental pulmonary embolism, symptomatic or incidental central catheter related thrombosis, or death from venous thromboembolism.","26 weeks after initiation of standard chemotherapy",[45,48,51,55],{"measure":46,"description":47,"timeFrame":43},"Major Bleeding Event","A categorical variable indicating whether the participant experienced a major bleeding event within 26 weeks of initiation of standard chemotherapy. A major bleeding event is defined by the occurrence of at least one of the following. Bleeding associated with death. Overt bleeding and associated with a decrease from baseline in hemoglobin concentration by at least 2.0 g\u002FL or with the need for transfusion of ≥ 2 units of whole blood or red cells. Bleeding in a critical area or organ such as retroperitoneal, intracranial, intraocular, intraspinal, intraarticular or pericardial, or intramuscular with compartment syndrome as determined by the investigator.",{"measure":49,"description":50,"timeFrame":43},"Clinically Relevant Non-Major Bleeding","A categorical variable indicating whether the participant experienced clinically relevant non-major bleeding within 26 weeks of initiation of standard chemotherapy. Clinically relevant non-major bleeding is defined as bleeding that leads to a medical intervention, an unscheduled contact with provider, temporary cessation of oral anticoagulants or antiplatelet agent, discomfort for the participant (such as pain) or impairment of activities of daily living.",{"measure":52,"description":53,"timeFrame":54},"Relapse-Free Survival (RFS)","Calculated from the date of enrollment to the date of first documented evidence of recurrent disease or death, whichever occurred first. For participants who have not relapsed, RFS will be censored at the last disease status assessment. Relapse will be determined by biopsy proven recurrent non-teratoma germ cell tumor, initiation of salvage chemotherapy, or rising tumor markers unequivocally.","2 years after initiation of standard chemotherapy",{"measure":56,"description":57,"timeFrame":54},"Overall Survival (OS)","Calculated from the date of enrollment to the date of death from any cause. Participants who are alive or lost to follow up at the time of the final analysis will be censored at the last known date they were alive.","ALL","18 Years","70 Years",false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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",[67,68],"ADULT","OLDER_ADULT",[70,88,101],{"facility":71,"status":7,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":85},"Atrium Health Wake Forest Baptist Comprehensive Cancer Center","Charlotte","North Carolina","28204","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Margarita Dzhanumova","CONTACT","980-515-5300","margarita.dzhanumova@advocatehealth.org",{"name":83,"role":84},"Landon Brown, MD","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},35.22709,-80.84313,{"facility":89,"status":7,"city":90,"state":73,"zip":91,"country":75,"contacts":92,"geoPoint":98},"Wake Forest Baptist Comprehensive Cancer Center","Winston-Salem","27157",[93,97],{"name":94,"role":79,"phone":95,"email":96},"Michael McCormack, MD","336-716-7975","Michael.McCormack@advocatehealth.org",{"name":94,"role":84},{"lat":99,"lon":100},36.09986,-80.24422,{"facility":102,"status":7,"city":103,"state":104,"zip":105,"country":75,"contacts":106,"geoPoint":113},"Aurora St. Luke's Medical Center MOB","Milwaukee","Wisconsin","53215",[107,111],{"name":108,"role":79,"phone":109,"email":110},"Milanka Petrovic","414-649-5391","milanka.petrovic@aah.org",{"name":112,"role":84},"Antony Ruggeri, MD",{"lat":114,"lon":115},43.0389,-87.90647,[117],{"name":78,"role":79,"phone":80,"email":81},[119],{"name":83,"affiliation":71,"role":84},[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[18,124],"Malignant Testicular Neoplasm",[],{"nct_id":4,"found":14,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is a single-arm, two-stage Phase II study, meaning all participants receive the same treatment. It plans to enroll up to 31 participants.","completed","Aspirin to Prevent Blood Clots in Advanced Germ Cell Tumors","This study is looking at whether taking a low dose of aspirin (81 mg daily) can help prevent blood clots (venous thromboembolism or VTE) in people with advanced germ cell tumors, including testicular cancer. You would take aspirin for 26 weeks while also receiving your standard chemotherapy. The study wants to see how many participants remain free of blood clots during this time. To join, you need to be between 18 and 70 years old and have a confirmed diagnosis of advanced germ cell cancer. The study is currently enrolling participants.","The main goal is measured at 26 weeks after starting chemotherapy, which is when you would also be taking aspirin.",91,"You would take 81 mg of aspirin by mouth daily for 26 weeks. You will need to provide your own supply of aspirin.","Not stated in the trial record.",[],"v2"]