Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin Chemotherapy and Bone Marrow Transplant

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Nabil Adra, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years - 100 Years Gender: Male Phase: N/A 2 Locations

Brief Description

Testicular cancer (TC) is diagnosed in young adult males between ages 18-39 and TC treatment involves the use of platinum therapy (CBCT) which can have long-term cardiovascular effects. We are looking at cholesterol and hormone changes, as well as blood vessel changes for coronary artery disease or blockages in the heart in the TC patients. We hope that findings from this study will help patients to be better screened for and treated for the possible long-term effects of chemotherapy and bone marrow transplant including cardiovascular disease and heart attack. 
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed Description

What will happen during the study?
  • Complete two procedures at a single clinic visit (up to 1 hr total).
  • Complete a questionnaire (approx 30-60 min).
  • Provide one blood sample for biomarker assessment that will help us analyze cholesterol, lipids, and platinum levels in the blood in relation to cardiovascular risk (blood will be obtained from the IV access used for a CT scan).
  • Undergo a Coronary CT Angiography (approx. 30 min), which is a well-established non-invasive imaging test that visualizes the coronary arteries with low risk (this Quick Scan includes the use of a contrast agent administered through an IV).
  • Participants will have the option to participate in a virtual visit or phone call with Dr. Clasen to discuss the results of their CCTA scan (approx 15-30 min).

Eligibility of study

Inclusion Criteria
  • 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.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.