Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Trial Title: Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

NCT ID: NCT05611307

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

Conditions: Official terms:
Testicular Neoplasms
Cardiovascular Diseases
Coronary Artery Disease
Lipid Metabolism Disorders
Hypogonadism
Eunuchism
Hormones

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Lipid profile
Description: Advanced lipid profile
Arm group label: Cisplatin-based chemotherapy (CBCT)
Arm group label: Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)
Arm group label: Surgical/Surveillance

Intervention type: Diagnostic Test
Intervention name: Coronary artery assessment
Description: Coronary artery assessment via CT scans
Arm group label: Cisplatin-based chemotherapy (CBCT)
Arm group label: Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)
Arm group label: Surgical/Surveillance

Intervention type: Diagnostic Test
Intervention name: Hormone levels for hypogonadism
Description: Hormone levels for hypogonadism
Arm group label: Cisplatin-based chemotherapy (CBCT)
Arm group label: Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)
Arm group label: Surgical/Surveillance

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.

Criteria for eligibility:

Study pop:
Testicular Cancer Patients who are disease free more than 10 years after diagnosis and treatment

Sampling method: Non-Probability Sample
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.

Gender: Male

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Indiana University

Address:
City: Indianapolis
Zip: 46202
Country: United States

Status: Recruiting

Contact:
Last name: Julie Lacy, RN

Phone: 317-274-0932
Email: julacy@iu.edu

Start date: October 11, 2022

Completion date: December 31, 2025

Lead sponsor:
Agency: Indiana University
Agency class: Other

Source: Indiana University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05611307