Investigating heart disease in testicular cancer survivors
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
This study is testing if testicular cancer survivors who had certain treatments are at higher risk for heart disease, using blood tests and imaging to find early signs of problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Indiana University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05611307 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on late subclinical cardiovascular disease in testicular cancer survivors who have undergone cisplatin-based chemotherapy and/or bone marrow transplant. It aims to evaluate the risk of atherosclerotic cardiovascular disease (ASCVD) in these patients, particularly those diagnosed with testicular cancer at a young age. The study will assess ASCVD risk through blood lipid biomarkers and advanced cardiac CT imaging, comparing three groups of survivors based on their treatment history. The goal is to identify early signs of cardiovascular issues to implement preventive measures.
Who should consider this trial
Good fit: Ideal candidates include testicular cancer survivors aged over 18 who are cancer-free and have undergone specific treatments such as cisplatin-based chemotherapy or bone marrow transplant.
Not a fit: Patients with a prior history of myocardial infarction or known atherosclerotic cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early detection and prevention of cardiovascular disease in young testicular cancer survivors.
How similar studies have performed: While there is ongoing research into cardiovascular risks in cancer survivors, this specific focus on testicular cancer survivors and their unique treatment history is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Suparna C Clasen, MD MSCE — Indiana University
- Study coordinator: Suparna Clasen, MD MSCE
- Email: scclasen@iu.edu
- Phone: 3179635462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.