Clinical trial NCT05611307: Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Official title: Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Testicular Cancer
Survivorship
ASCVD
Coronary Artery Disease
Lipid Disorder
Hypogonadism, Male
Cisplatin Adverse Reaction
Bone Marrow Transplant Complications
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Testicular Cancer Patients who are disease free more than 10 years after diagnosis and treatment

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

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 ≥ 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lipid profile
timeFrame: More than 10 years after testicular cancer diagnosis, At recruitment
measure: Coronary plaque assessment
timeFrame: More than 10 years after testicular cancer diagnosis, At recruitment
Secondary outcomes:
measure: Hormone levels
timeFrame: More than 10 years after testicular cancer diagnosis, At recruitment
measure: Serum platinum
timeFrame: More than 10 years after testicular cancer diagnosis, At recruitment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Suparna C Clasen, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: