Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Study Details
Study Description
Brief Summary
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
Condition or Disease | Intervention/Treatment | Phase |
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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 ≥ 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Surgical/Surveillance TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1) |
Diagnostic Test: Lipid profile
Advanced lipid profile
Diagnostic Test: Coronary artery assessment
Coronary artery assessment via CT scans
Diagnostic Test: Hormone levels for hypogonadism
Hormone levels for hypogonadism
|
Cisplatin-based chemotherapy (CBCT) TCS treat with one or more lines of cisplatin-based chemotherapy |
Diagnostic Test: Lipid profile
Advanced lipid profile
Diagnostic Test: Coronary artery assessment
Coronary artery assessment via CT scans
Diagnostic Test: Hormone levels for hypogonadism
Hormone levels for hypogonadism
|
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 |
Diagnostic Test: Lipid profile
Advanced lipid profile
Diagnostic Test: Coronary artery assessment
Coronary artery assessment via CT scans
Diagnostic Test: Hormone levels for hypogonadism
Hormone levels for hypogonadism
|
Outcome Measures
Primary Outcome Measures
- Lipid profile [More than 10 years after testicular cancer diagnosis, At recruitment]
HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws
- Coronary plaque assessment [More than 10 years after testicular cancer diagnosis, At recruitment]
Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans
Secondary Outcome Measures
- Hormone levels [More than 10 years after testicular cancer diagnosis, At recruitment]
Measurement of testosterone
- Serum platinum [More than 10 years after testicular cancer diagnosis, At recruitment]
Measurement of residual serum platinum levels
Eligibility Criteria
Criteria
Inclusion Criteria
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Patients >18 years of age
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Patients will be recruited only if cancer-free at clinical evaluation time.
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For the cases a confirmed TC diagnosis who received one or more cycles of CBCT-based chemotherapies (CBCT group, Arm 2)
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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).
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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
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Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
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Significant renal disease (GFR<40)
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Allergy to iodinated contrast
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Antecedent chemotherapy for another primary cancer.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Indiana University | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Suparna C Clasen, MD MSCE, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12751