Recruiting

Observational StudyLate Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Sponsor:

Indiana University

Code:

NCT05611307

Conditions

Testicular Cancer

Survivorship

ASCVD

Coronary Artery Disease

Lipid Disorder

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lipid profile

Coronary artery assessment

Hormone levels for hypogonadism

Study Details

Brief summary:

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

Conditions

Testicular Cancer

Survivorship

ASCVD

Coronary Artery Disease

Lipid Disorder

Study ID

NCT05611307

Start date

Oct 11, 2022

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Surgical/Surveillance

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

Cisplatin-based chemotherapy (CBCT)

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

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

Interventions

Lipid profile

Advanced lipid profile

Coronary artery assessment

Coronary artery assessment via CT scans

Hormone levels for hypogonadism

Primary outcome measure

Lipid profile [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Elizabeth Rowe

317-278-1185 rowee@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Elizabeth Rowe

(317) 278-1185 rowee@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-27.