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临床试验/NCT05611307
NCT05611307招募中不适用

Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant

Indiana University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年10月11日最近更新:
适应症
干预措施

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noah Richardson

Assistant Professor of Clinical Medicine

Indiana University

研究点 (1)

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