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

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Cisplatin Adverse Reaction; Lipid Disorder; Survivorship; Hypogonadism, Male; Testicular Cancer; Bone Marrow Transplant Complications; ASCVD
• Intervention / Treatment: Diagnostic test: Lipid profile; Diagnostic test: Coronary artery assessment; Diagnostic test: Hormone levels for hypogonadism

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical/Surveillance; TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)	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
Cisplatin-based chemotherapy (CBCT); TCS treat with one or more lines of cisplatin-based chemotherapy	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
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT); TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws	More than 10 years after testicular cancer diagnosis, At recruitment
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hormone levels	Measurement of testosterone	More than 10 years after testicular cancer diagnosis, At recruitment
Serum platinum	Measurement of residual serum platinum levels	More than 10 years after testicular cancer diagnosis, At recruitment

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Suparna C Clasen, MD MSCE, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Vascular Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Heart Diseases; Metabolic Diseases; Endocrine Gland Neoplasms; Gonadal Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Testicular Diseases; Cardiovascular Diseases; Hypogonadism; Coronary Artery Disease; Lipid Metabolism Disorders; Testicular Neoplasms; Eunuchism; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 12751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No