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Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05611307
Collaborator
(none)
150
Enrollment
1
Location
38.7
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Lipid profile
  • Diagnostic Test: Coronary artery assessment
  • Diagnostic Test: Hormone levels for hypogonadism

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant
Actual Study Start Date :
Oct 11, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Surgical/Surveillance

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

Diagnostic Test: Lipid profile
Advanced lipid profile

Diagnostic Test: Coronary artery assessment
Coronary artery assessment via CT scans

Diagnostic Test: Hormone levels for hypogonadism
Hormone levels for hypogonadism
Cisplatin-based chemotherapy (CBCT)

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

Diagnostic Test: Lipid profile
Advanced lipid profile

Diagnostic Test: Coronary artery assessment
Coronary artery assessment via CT scans

Diagnostic Test: Hormone levels for hypogonadism
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
Advanced lipid profile

Diagnostic Test: Coronary artery assessment
Coronary artery assessment via CT scans

Diagnostic Test: Hormone levels for hypogonadism
Hormone levels for hypogonadism

Outcome Measures

Primary Outcome Measures

  1. Lipid profile [More than 10 years after testicular cancer diagnosis, At recruitment]

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

  2. Coronary plaque assessment [More than 10 years after testicular cancer diagnosis, At recruitment]

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

Secondary Outcome Measures

  1. Hormone levels [More than 10 years after testicular cancer diagnosis, At recruitment]

    Measurement of testosterone

  2. Serum platinum [More than 10 years after testicular cancer diagnosis, At recruitment]

    Measurement of residual serum platinum levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University

Investigators

  • Principal Investigator: Suparna C Clasen, MD MSCE, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suparna C. Clasen, Medical Director of Cardio-Oncology Director of Clinical Research Operations, Krannert Cardiovascular Research, Indiana University
ClinicalTrials.gov Identifier:
NCT05611307
Other Study ID Numbers:
  • 12751
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Testicular Neoplasms
Cardiovascular Diseases
Coronary Artery Disease
Lipid Metabolism Disorders
Hypogonadism
Eunuchism
Hormones

Study Results

No Results Posted as of Nov 10, 2022