Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611307
• Other study ID #: 12751
• Status: Recruiting
• Start date: October 11, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Indiana University
• Contact: Suparna Clasen, MD MSCE
• Phone: 3179635462
• Email: scclasen[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• ASCVD
• Bone Marrow Transplant Complications
• Cardiovascular Diseases
• Cisplatin Adverse Reaction
• Coronary Artery Disease
• Hypogonadism
• Hypogonadism, Male
• Lipid Disorder
• Lipid Metabolism Disorders
• Survivorship
• Testicular Cancer
• Testicular Neoplasms

Intervention

Diagnostic Test:
• Lipid profile
Advanced lipid profile
• Coronary artery assessment
Coronary artery assessment via CT scans
• Hormone levels for hypogonadism
Hormone levels for hypogonadism

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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