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NCT05611307

Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

See at-risk trials from Indiana University

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Jul 2027
    • Study completion pushed from Aug 2027 to Mar 2028
    • Eligibility criteria expanded, about 9 words
  2. Trial status: Terminated to Recruitingv6 Show 7 more changesShow less
    • Enrollment target: 31 to 150
    • Primary completion date: Dec 4, 2024 to Dec 2026
    • Study completion date: Dec 4, 2024 to Aug 2027
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised
    • Collaborators: 1 to 2
  3. Trial status: Recruiting to Terminated Sponsor's reason: PI leaving Institutionv5 Show 4 more changesShow less
    • Enrollment target: estimated 150 to confirmed 31
    • Primary completion date changed from estimate of Dec 31, 2026 to Dec 4, 2024
    • Study completion date changed from estimate of Aug 31, 2027 to Dec 4, 2024
    • Site details revised
  4. Site contact updated
    • Collaborators expanded, about 5 words
    v4
  5. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Aug 31, 2027
    v3
  6. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Lipid profile
Timeframe: More than 5 years after testicular cancer diagnosis, At recruitment
Coronary plaque assessment
Timeframe: More than 5 years after testicular cancer diagnosis, At recruitment

Secondary (2)

Hormone levels
Serum platinum

Arms and interventions

Surgical/Surveillance

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

Cisplatin-based chemotherapy (CBCT)

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

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 tests: Lipid profile, Coronary artery assessment, Hormone levels for hypogonadism

Sites

1 site in 1 country

  • Indiana UniversityIndianapolis, Indiana, United States