Detection of late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin chemotherapy and bone marrow transplant
S
Suparna C. Clasen, MD, MSCE
Primary Investigator
Enrolling By Invitation
18-100 years
Male
Phase
N/A
150 participants needed
2 Locations
Overview
Why is this study being done?
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.
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
Email: iutrials@iu.edu
Phone: (317) 278-5632
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).
Incentive/compensation
- You will receive a parking voucher and a $125 payment card for completing all of the study requirements.
Additional information: The study is being conducted by Dr.
Suparna C. Clasen, MD MSCE and a team of researchers from the Indiana
University School of Medicine, Indiana University Simon Comprehensive
Cancer Center, and the Indiana University Health Physicians Cardiology.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Testicular Cancer, ASCVD, Bone Marrow Transplant Complications, Cisplatin Adverse Reaction, Coronary Artery Disease, Hypogonadism, Male Lipid Disorder, Cancer Survivorship
-
Age: Between 18 Years - 100 Years
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Gender: Male
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.
Updated on
28 Aug 2024.
Study ID: KIC-IIR-CLASEN-ASCVD, 12751, NCT05611307
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