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Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

ConditionsTesticular CancerSurvivorshipASCVDCoronary Artery DiseaseLipid DisorderHypogonadism, MaleCisplatin Adverse ReactionBone Marrow Transplant Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-99
SponsorIndiana University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)

Significant renal disease (GFR<40)

Allergy to iodinated contrast

Antecedent chemotherapy for another primary cancer.

Trial population

Testicular Cancer Patients who are disease free more than 5 years after diagnosis and treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Surgical/Surveillance3 interventions
Group B: Cisplatin-based chemotherapy (CBCT)3 interventions
Group C: Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

JDS Foundation Testis Cancer Clinical Trials Support Fund

Collaborator

Source ClinicalTrials.gov
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