Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Indiana University

Status: Terminated

Conditions: Cisplatin Adverse Reaction; Testicular Cancer; Bone Marrow Transplant Complications; Coronary Artery Disease; Lipid Disorder; Survivorship; Hypogonadism, Male; ASCVD

Treatments: Diagnostic Test: Hormone levels for hypogonadism; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Lipid profile

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05611307

12751

Details and patient eligibility

About

Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant

Full 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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

31 participants in 3 patient groups

Surgical/Surveillance

Description:

TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)

Treatment:

Diagnostic Test: Coronary artery assessment

Diagnostic Test: Lipid profile

Diagnostic Test: Hormone levels for hypogonadism

Cisplatin-based chemotherapy (CBCT)

Description:

TCS treat with one or more lines of cisplatin-based chemotherapy

Treatment:

Diagnostic Test: Coronary artery assessment

Diagnostic Test: Lipid profile

Diagnostic Test: Hormone levels for hypogonadism

Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)

Description:

TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant

Treatment:

Diagnostic Test: Coronary artery assessment

Diagnostic Test: Lipid profile

Diagnostic Test: Hormone levels for hypogonadism