Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Recruiting

• Conditions: ASCVD; Lipid Disorder; Bone Marrow Transplant Complications; Survivorship; Coronary Artery Disease; Cisplatin Adverse Reaction; Hypogonadism, Male; Testicular Cancer
• Interventions: Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism

• Registration Number: NCT05611307
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study Start: 2022-10-11
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)	Lipid profile	TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant
Surgical/Surveillance	Lipid profile	TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)
Surgical/Surveillance	Hormone levels for hypogonadism	TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)
Cisplatin-based chemotherapy (CBCT)	Coronary artery assessment	TCS treat with one or more lines of cisplatin-based chemotherapy
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)	Hormone levels for hypogonadism	TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant
Surgical/Surveillance	Coronary artery assessment	TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)
Cisplatin-based chemotherapy (CBCT)	Hormone levels for hypogonadism	TCS treat with one or more lines of cisplatin-based chemotherapy
Cisplatin-based chemotherapy (CBCT)	Lipid profile	TCS treat with one or more lines of cisplatin-based chemotherapy
Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)	Coronary artery assessment	TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant

Primary Outcome Measures

Name	Time	Method
Coronary plaque assessment	More than 10 years after testicular cancer diagnosis, At recruitment	Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans
Lipid profile	More than 10 years after testicular cancer diagnosis, At recruitment	HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws

Secondary Outcome Measures

Name	Time	Method
Serum platinum	More than 10 years after testicular cancer diagnosis, At recruitment	Measurement of residual serum platinum levels
Hormone levels	More than 10 years after testicular cancer diagnosis, At recruitment	Measurement of testosterone

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States