Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Indiana University31 enrolled

Overview

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 ≥ 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Lipid profileDIAGNOSTIC_TEST

Advanced lipid profile

Coronary artery assessmentDIAGNOSTIC_TEST

Coronary artery assessment via CT scans

Hormone levels for hypogonadismDIAGNOSTIC_TEST

Hormone levels for hypogonadism

Eligibility

Sex: MALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Lipid profile

HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws

Time frame: 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

Time frame: More than 10 years after testicular cancer diagnosis, At recruitment

Secondary Outcomes

Hormone levels

Measurement of testosterone

Time frame: More than 10 years after testicular cancer diagnosis, At recruitment

Serum platinum

Measurement of residual serum platinum levels

Time frame: More than 10 years after testicular cancer diagnosis, At recruitment

Data from ClinicalTrials.gov

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