Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Study Overview
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Brief Summary
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Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant

Detailed Description
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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 ≥ 10 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.

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

Conditions
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Testicular Cancer, Survivorship, ASCVD, Coronary Artery Disease, Lipid Disorder, Hypogonadism, Male, Cisplatin Adverse Reaction, Bone Marrow Transplant Complications

Intervention / Treatment
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* Diagnostic Test: Lipid profile
* Diagnostic Test: Coronary artery assessment
* Diagnostic Test: Hormone levels for hypogonadism


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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) Exclusion Criteria Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD) Significant renal disease (GFR<40) Allergy to iodinated contrast Antecedent chemotherapy for another primary cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical/Surveillance<br>TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1) | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
| Cisplatin-based chemotherapy (CBCT)<br>TCS treat with one or more lines of cisplatin-based chemotherapy | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|
| Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)<br>TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant | Diagnostic Test: Lipid profile<br>* Advanced lipid profile<br>Diagnostic Test: Coronary artery assessment<br>* Coronary artery assessment via CT scans<br>Diagnostic Test: Hormone levels for hypogonadism<br>* Hormone levels for hypogonadism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws | More than 10 years after testicular cancer diagnosis, At recruitment | 
| Coronary plaque assessment | Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans | More than 10 years after testicular cancer diagnosis, At recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone levels | Measurement of testosterone | More than 10 years after testicular cancer diagnosis, At recruitment | 
| Serum platinum | Measurement of residual serum platinum levels | More than 10 years after testicular cancer diagnosis, At recruitment |