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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05611307
Other study ID # 12751
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 11, 2022
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Indiana University
Contact Suparna Clasen, MD MSCE
Phone 3179635462
Email scclasen@iu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Lipid profile
Advanced lipid profile
Coronary artery assessment
Coronary artery assessment via CT scans
Hormone levels for hypogonadism
Hormone levels for hypogonadism

Locations

Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lipid profile HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws More than 10 years after testicular cancer diagnosis, At recruitment
Primary Coronary plaque assessment Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans More than 10 years after testicular cancer diagnosis, At recruitment
Secondary Hormone levels Measurement of testosterone More than 10 years after testicular cancer diagnosis, At recruitment
Secondary Serum platinum Measurement of residual serum platinum levels More than 10 years after testicular cancer diagnosis, At recruitment
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