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NCT Number: NCT05611307

Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

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

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Key information

About this study

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 ≥ 5 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipid profile

Diagnostic Test

Advanced lipid profile

Coronary artery assessment

Diagnostic Test

Coronary artery assessment via CT scans

Hormone levels for hypogonadism

Diagnostic Test

Hormone levels for hypogonadism

Primary outcomes

  1. Lipid profile

    Time frame: More than 5 years after testicular cancer diagnosis, At recruitment

    HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws

  2. Coronary plaque assessment

    Time frame: More than 5 years after testicular cancer diagnosis, At recruitment

    Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans

Secondary outcomes

  1. Hormone levels

    Time frame: More than 5 years after testicular cancer diagnosis, At recruitment

    Measurement of testosterone

  2. Serum platinum

    Time frame: More than 5 years after testicular cancer diagnosis, At recruitment

    Measurement of residual serum platinum levels

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Rowe

CONTACT

[email protected]

317-278-1185

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • JDS Foundation Testis Cancer Clinical Trials Support Fund
  • National Institutes of Health (NIH)

Registry information

Official study title

Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 10, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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