Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lipid profile, Coronary artery assessment, Hormone levels for hypogonadism.
- Who it may be relevant to
- Registry conditions: Testicular Cancer, Survivorship, ASCVD, Coronary Artery Disease. Basic parameters: 18 years — 99 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
Overview
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 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
Primary outcome measures
- Lipid profile [Time frame: More than 5 years after testicular cancer diagnosis, At recruitment]
- Coronary plaque assessment [Time frame: More than 5 years after testicular cancer diagnosis, At recruitment]
Secondary outcome measures (2)
- Hormone levels [Time frame: More than 5 years after testicular cancer diagnosis, At recruitment]
- Serum platinum [Time frame: More than 5 years after testicular cancer diagnosis, At recruitment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Indiana University — Indianapolis
Identifiers
NCT: NCT05611307 · 12751