Trials / Terminated
TerminatedNCT05611307
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 31 (actual)
- Sponsor
- Indiana University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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 ≥ 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.
Conditions
- Testicular Cancer
- Survivorship
- ASCVD
- Coronary Artery Disease
- Lipid Disorder
- Hypogonadism, Male
- Cisplatin Adverse Reaction
- Bone Marrow Transplant Complications
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-10-11
- Primary completion
- 2024-12-04
- Completion
- 2024-12-04
- First posted
- 2022-11-10
- Last updated
- 2025-08-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05611307. Inclusion in this directory is not an endorsement.