Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

July 23, 2026 updated by: Noah Richardson, Indiana University

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

Recruiting

Conditions

Intervention / Treatment

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 ≥ 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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elizabeth Rowe
  • Phone Number: 317-278-1185
  • Email: rowee@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Elizabeth Rowe
          • Phone Number: (317) 278-1185
          • Email: rowee@iu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 5 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: More than 5 years after testicular cancer diagnosis, At recruitment
HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws
More than 5 years after testicular cancer diagnosis, At recruitment
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
More than 5 years after testicular cancer diagnosis, At recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormone levels
Time Frame: More than 5 years after testicular cancer diagnosis, At recruitment
Measurement of testosterone
More than 5 years after testicular cancer diagnosis, At recruitment
Serum platinum
Time Frame: More than 5 years after testicular cancer diagnosis, At recruitment
Measurement of residual serum platinum levels
More than 5 years after testicular cancer diagnosis, At recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Investigators

  • Principal Investigator: Noah Richardson, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 1, 2027

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)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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