[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05611307":3,"trial-entities:NCT05611307":108,"trial-summary:NCT05611307":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":50,"secondary_outcomes":57,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":81,"locations":84,"central_contacts":99,"overall_officials":102,"references":106,"see_also_links":107},"NCT05611307","12751","Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors","Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant","RECRUITING","2027-08","2026-07","2026-07-27","2022-10-11","Indiana University","OTHER",true,"Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant","Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 5 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection\u002Fsurveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.",[19,20,21,22,23,24,25,26],"Testicular Cancer","Survivorship","ASCVD","Coronary Artery Disease","Lipid Disorder","Hypogonadism, Male","Cisplatin Adverse Reaction","Bone Marrow Transplant Complications",[],"OBSERVATIONAL",null,[],{"count":32,"type":33},150,"ESTIMATED",[35,43,47],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DIAGNOSTIC_TEST","Lipid profile","Advanced lipid profile",[40,41,42],"Cisplatin-based chemotherapy (CBCT)","Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT\u002FBMT)","Surgical\u002FSurveillance",{"type":36,"name":44,"description":45,"armGroupLabels":46},"Coronary artery assessment","Coronary artery assessment via CT scans",[40,41,42],{"type":36,"name":48,"description":48,"armGroupLabels":49},"Hormone levels for hypogonadism",[40,41,42],[51,54],{"measure":37,"description":52,"timeFrame":53},"HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws","More than 5 years after testicular cancer diagnosis, At recruitment",{"measure":55,"description":56,"timeFrame":53},"Coronary plaque assessment","Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans",[58,61],{"measure":59,"description":60,"timeFrame":53},"Hormone levels","Measurement of testosterone",{"measure":62,"description":63,"timeFrame":53},"Serum platinum","Measurement of residual serum platinum levels","MALE","18 Years","99 Years",false,{"inclusion":69,"exclusion":75,"raw_text":80},[70,71,72,73,74],"Patients \\>18 years of age","Patients will be recruited only if cancer-free at clinical evaluation time.","For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)","For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT \\& BMT group, Arm 3).","For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical\u002Fsurveillance, Arm 1)",[76,77,78,79],"Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)","Significant renal disease (GFR\\\u003C40)","Allergy to iodinated contrast","Antecedent chemotherapy for another primary cancer.","Inclusion Criteria\n\n* Patients \\>18 years of age\n* Patients will be recruited only if cancer-free at clinical evaluation time.\n* For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)\n* For the cases with a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies and underwent BMT for relapsed refractory disease (CBCT \\& BMT group, Arm 3).\n* For the comparison cohort, biopsy-proven TC patients who had surgery for or surveillance of their testicular cancer and never received CBCTCBCT or BMT (surgical\u002Fsurveillance, Arm 1)\n\nExclusion Criteria\n\n* Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)\n* Significant renal disease (GFR\\\u003C40)\n* Allergy to iodinated contrast\n* Antecedent chemotherapy for another primary cancer.",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"Indianapolis","Indiana","46202","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Elizabeth Rowe","CONTACT","(317) 278-1185","rowee@iu.edu",{"lat":97,"lon":98},39.76838,-86.15804,[100],{"name":92,"role":93,"phone":101,"email":95},"317-278-1185",[103],{"name":104,"affiliation":13,"role":105},"Noah Richardson, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Malignant Testicular Neoplasm",[],{"nct_id":4,"found":15,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an observational study with a planned enrollment of 150 men. It is not a treatment study but rather looks at health outcomes in different groups of testicular cancer survivors.","completed","Observational Study on Heart Disease in Testicular Cancer Survivors","This observational study is looking at heart and blood vessel disease (atherosclerotic cardiovascular disease or ASCVD) in men who have survived testicular cancer. Researchers want to understand if certain treatments for testicular cancer, like cisplatin-based chemotherapy (CBCT) or bone marrow transplant (BMT), increase the risk of heart problems later in life. You might be eligible if you are a man aged 18 to 99, are cancer-free, and had testicular cancer treated with CBCT, or CBCT plus BMT, or surgery\u002Fsurveillance only. The study will assess your lipid profile (fats in your blood) and check for plaque in your coronary arteries (heart arteries) using CT scans. The goal is to find ways to detect heart disease earlier in testicular cancer survivors.","The primary endpoints, lipid profile and coronary plaque assessment, are measured at recruitment and more than 5 years after testicular cancer diagnosis.",119,"Participants will undergo an advanced lipid profile blood test, a coronary artery assessment via CT scans, and hormone level testing for hypogonadism.","Not stated in the trial record.",[37],"v2"]