Coronary Artery Disease Clinical Trial
Official title:
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
NCT number | NCT05611307 |
Other study ID # | 12751 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 11, 2022 |
Est. completion date | December 31, 2025 |
Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid profile | HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws | More than 10 years after testicular cancer diagnosis, At recruitment | |
Primary | Coronary plaque assessment | Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans | More than 10 years after testicular cancer diagnosis, At recruitment | |
Secondary | Hormone levels | Measurement of testosterone | More than 10 years after testicular cancer diagnosis, At recruitment | |
Secondary | Serum platinum | Measurement of residual serum platinum levels | More than 10 years after testicular cancer diagnosis, At recruitment |
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