Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

NCT05611307 | Recruiting DMC

• 1 other identifier: 12751
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Testicular Cancer; Survivorship; ASCVD; Coronary Artery Disease; Lipid Disorder; Hypogonadism, Male; Cisplatin Adverse Reaction; Bone Marrow Transplant Complications

Outcome Measures

Primary Outcomes (2)

• Lipid profile

  HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws

  More than 5 years after testicular cancer diagnosis, At recruitment

• Coronary plaque assessment

  Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans

  More than 5 years after testicular cancer diagnosis, At recruitment

Secondary Outcomes (2)

• Hormone levels

  More than 5 years after testicular cancer diagnosis, At recruitment

• Serum platinum

  More than 5 years after testicular cancer diagnosis, At recruitment

Study Arms (3)

Surgical/Surveillance

TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)

Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism

Cisplatin-based chemotherapy (CBCT)

TCS treat with one or more lines of cisplatin-based chemotherapy

Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism

Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)

TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant

Diagnostic Test: Lipid profile; Diagnostic Test: Coronary artery assessment; Diagnostic Test: Hormone levels for hypogonadism

Interventions

Lipid profile DIAGNOSTIC_TEST

Advanced lipid profile

Cisplatin-based chemotherapy (CBCT); Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT); Surgical/Surveillance

Coronary artery assessment DIAGNOSTIC_TEST

Coronary artery assessment via CT scans

Cisplatin-based chemotherapy (CBCT); Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT); Surgical/Surveillance

Hormone levels for hypogonadism DIAGNOSTIC_TEST

Hormone levels for hypogonadism

Cisplatin-based chemotherapy (CBCT); Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT); Surgical/Surveillance

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Prior known myocardial infarction (MI), atherosclerotic cardiovascular disease (ASCVD)
• Significant renal disease (GFR\<40)
• Allergy to iodinated contrast
• Antecedent chemotherapy for another primary cancer.

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator
• JDS Foundation Testis Cancer Clinical Trials Support Fund: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms; Coronary Artery Disease; Lipid Metabolism Disorders; Eunuchism

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypogonadism

Study Officials

• Noah Richardson, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Rowe

CONTACT

317-278-1185; rowee@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 10, 2022
• Study Start: October 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)