ClinicalTrials.gg
RecruitingNCT05611307Updated Oct 30, 2026

Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

An observational study in Testicular Cancer, Survivorship and ASCVD, sponsored by Indiana University. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Indiana University · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Updated Oct 30, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 99 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Testicular Cancer
  • Survivorship
  • ASCVD
  • Coronary Artery Disease
  • Lipid Disorder
  • Hypogonadism, Male
  • Cisplatin Adverse Reaction
  • Bone Marrow Transplant Complications
03

In context

Testicular Neoplasms

295 studies on the registry are indexed under Testicular Neoplasms; 51 are open to participants now.

This study's planned enrollment of 150 is above the median of 133 across 73 observational studies indexed under Testicular Neoplasms.

Browse Testicular Neoplasms studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Male
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 refractory disease (CBCT \& BMT group, Arm 3).
  • For the comparison cohort, -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

Exclusion Criteria

  • Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
  • Significant renal disease (\<40)
  • Allergy to iodinated contrast
  • Antecedent chemotherapy for another primary cancer.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Surgical/Surveillance

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

    Diagnostic Test: Lipid profile · Diagnostic Test: Coronary artery assessment · Diagnostic Test: Hormone levels for hypogonadism

  • Cisplatin-based chemotherapy (CBCT)

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

    Diagnostic Test: Lipid profile · Diagnostic Test: Coronary artery assessment · 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

    Diagnostic Test: Lipid profile · Diagnostic Test: Coronary artery assessment · Diagnostic Test: Hormone levels for hypogonadism

Interventions

  • Diagnostic testLipid profile

    Advanced lipid profile

  • Diagnostic testCoronary artery assessment

    Coronary artery assessment via CT scans

  • Diagnostic testHormone levels for hypogonadism

    Hormone levels for hypogonadism

06

What researchers measure

Primary outcomes

  1. Lipid profile

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

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

  2. Coronary plaque assessment

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

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

Secondary outcomes

  1. Hormone levels

    Measurement of testosterone

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

  2. Serum platinum

    Measurement of residual serum platinum levels

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 2026→Jul 2027
Oct 30, 2026
Study completion
Aug 2027→Mar 2028
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Primary completion Dec 2026→Jul 2027
    Study completion Aug 2027→Mar 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05611307
Lead sponsor
Indiana University
Collaborators
National Institutes of Health (NIH), JDS Foundation Testis Cancer Clinical Trials Support Fund
Responsible party
Noah Richardson (Assistant Professor of Clinical Medicine, Indiana University) — Principal investigator
First posted
Nov 10, 2022
Start date
Oct 11, 2022
Primary completion
Jul 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Oct 30, 2026

Study contacts

Elizabeth Rowe
Contact
rowee@iu.edu
317-278-1185
Noah Richardson, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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