Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Lipid profile
研究概览
简要总结
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
详细描述
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/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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/surveillance, Arm 1)
排除标准
- •Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
- •Significant renal disease (GFR<40)
- •Allergy to iodinated contrast
- •Antecedent chemotherapy for another primary cancer.
研究组 & 干预措施
Surgical/Surveillance
TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)
干预措施: Coronary artery assessment (Diagnostic Test)
Surgical/Surveillance
TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)
干预措施: Hormone levels for hypogonadism (Diagnostic Test)
Surgical/Surveillance
TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)
干预措施: Lipid profile (Diagnostic Test)
Cisplatin-based chemotherapy (CBCT)
TCS treat with one or more lines of cisplatin-based chemotherapy
干预措施: Lipid profile (Diagnostic Test)
Cisplatin-based chemotherapy (CBCT)
TCS treat with one or more lines of cisplatin-based chemotherapy
干预措施: Coronary artery assessment (Diagnostic Test)
Cisplatin-based chemotherapy (CBCT)
TCS treat with one or more lines of cisplatin-based chemotherapy
干预措施: Hormone levels for hypogonadism (Diagnostic Test)
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)
TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant
干预措施: Lipid profile (Diagnostic Test)
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)
TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant
干预措施: Coronary artery assessment (Diagnostic Test)
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)
TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant
干预措施: Hormone levels for hypogonadism (Diagnostic Test)
结局指标
主要结局
Lipid profile
时间窗: More than 5 years after testicular cancer diagnosis, At recruitment
HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws
Coronary plaque assessment
时间窗: More than 5 years after testicular cancer diagnosis, At recruitment
Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans
次要结局
- Hormone levels(More than 5 years after testicular cancer diagnosis, At recruitment)
- Serum platinum(More than 5 years after testicular cancer diagnosis, At recruitment)
研究者
Noah Richardson
Assistant Professor of Clinical Medicine
Indiana University
