NCT05611307

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

October 21, 2022

Last Update Submit

August 6, 2025

Conditions

Testicular CancerSurvivorshipASCVDCoronary Artery DiseaseLipid DisorderHypogonadism, MaleCisplatin Adverse ReactionBone Marrow Transplant Complications

Outcome Measures

Primary Outcomes (2)

  • Lipid profile

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

    More than 10 years after testicular cancer diagnosis, At recruitment

  • 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 Outcomes (2)

  • Hormone levels

    More than 10 years after testicular cancer diagnosis, At recruitment

  • Serum platinum

    More than 10 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 profileDiagnostic Test: Coronary artery assessmentDiagnostic Test: Hormone levels for hypogonadism

Cisplatin-based chemotherapy (CBCT)

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

Diagnostic Test: Lipid profileDiagnostic Test: Coronary artery assessmentDiagnostic 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 profileDiagnostic Test: Coronary artery assessmentDiagnostic Test: Hormone levels for hypogonadism

Interventions

Lipid profileDIAGNOSTIC_TEST

Advanced lipid profile

Cisplatin-based chemotherapy (CBCT)Cisplatin-based chemotherapy and Bone Marrow Transplant (CBCT/BMT)Surgical/Surveillance
Coronary artery assessmentDIAGNOSTIC_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 hypogonadismDIAGNOSTIC_TEST

Hormone levels for hypogonadism

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

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Testicular Cancer Patients who are disease free more than 10 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Testicular NeoplasmsCoronary Artery DiseaseLipid Metabolism DisordersEunuchism

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesHypogonadism

Study Officials

  • Suparna C Clasen, MD MSCE

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Cardio-Oncology Director of Clinical Research Operations, Krannert Cardiovascular Research

Study Record Dates

First Submitted

October 21, 2022

First Posted

November 10, 2022

Study Start

October 11, 2022

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)