ASCVD, Bone Marrow Transplant Complications, Cisplatin Adverse Reaction, Coronary Artery Disease, Hypogonadism, Male, Lipid Disorder, Survivorship, Testicular Cancer
Conditions
Brief summary
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
Detailed description
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.
Interventions
DIAGNOSTIC_TESTLipid profile
Advanced lipid profile
DIAGNOSTIC_TESTCoronary artery assessment
Coronary artery assessment via CT scans
DIAGNOSTIC_TESTHormone levels for hypogonadism
Hormone levels for hypogonadism
Sponsors
Indiana University
National Institutes of Health (NIH)
JDS Foundation Testis Cancer Clinical Trials Support Fund
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | More than 5 years after testicular cancer diagnosis, At recruitment | HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws |
| Coronary plaque assessment | More than 5 years after testicular cancer diagnosis, At recruitment | Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormone levels | More than 5 years after testicular cancer diagnosis, At recruitment | Measurement of testosterone |
| Serum platinum | More than 5 years after testicular cancer diagnosis, At recruitment | Measurement of residual serum platinum levels |
Countries
United States
Contacts
CONTACTElizabeth Rowe
PRINCIPAL_INVESTIGATORNoah Richardson, MD
Indiana University
Outcome results
None listed