Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

NCT ID: NCT05611307

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-11

Study Completion Date

2024-12-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Testicular Cancer Survivorship ASCVD Coronary Artery Disease Lipid Disorder Hypogonadism, Male Cisplatin Adverse Reaction Bone Marrow Transplant Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical/Surveillance

TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)

Lipid profile

Intervention Type DIAGNOSTIC_TEST

Advanced lipid profile

Coronary artery assessment

Intervention Type DIAGNOSTIC_TEST

Coronary artery assessment via CT scans

Hormone levels for hypogonadism

Intervention Type DIAGNOSTIC_TEST

Hormone levels for hypogonadism

Cisplatin-based chemotherapy (CBCT)

TCS treat with one or more lines of cisplatin-based chemotherapy

Lipid profile

Intervention Type DIAGNOSTIC_TEST

Advanced lipid profile

Coronary artery assessment

Intervention Type DIAGNOSTIC_TEST

Coronary artery assessment via CT scans

Hormone levels for hypogonadism

Intervention Type DIAGNOSTIC_TEST

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

Lipid profile

Intervention Type DIAGNOSTIC_TEST

Advanced lipid profile

Coronary artery assessment

Intervention Type DIAGNOSTIC_TEST

Coronary artery assessment via CT scans

Hormone levels for hypogonadism

Intervention Type DIAGNOSTIC_TEST

Hormone levels for hypogonadism

Interventions

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Lipid profile

Advanced lipid profile

Intervention Type DIAGNOSTIC_TEST

Coronary artery assessment

Coronary artery assessment via CT scans

Intervention Type DIAGNOSTIC_TEST

Hormone levels for hypogonadism

Hormone levels for hypogonadism

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Suparna C. Clasen

Medical Director of Cardio-Oncology Director of Clinical Research Operations, Krannert Cardiovascular Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suparna C Clasen, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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12751

Identifier Type: -

Identifier Source: org_study_id

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