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Clinical Trials/NL-OMON51839
NL-OMON51839
Recruiting
Not Applicable

Immune checkpoint inhibition associated cardiovascular adverse events in cancer patients - ITHACA

Academisch Medisch Centrum0 sites214 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
cardiovascular disease (CVD)
Sponsor
Academisch Medisch Centrum
Enrollment
214
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- Adult male or female, age \>\=50 years
  • \- Prior to start therapy
  • \- Confirmed diagnosis of cancer:
  • \- Treatment\-naive advanced esophageal, gastric, or gastro\-esophageal cancer
  • planned for first\-line nivolumab or chemotherapy only or follow\-up only after
  • \- Treatment\-naive advanced colorectal cancer planned for first\-line
  • pembrolizumab or other systemic therapies
  • \- Recurrent or metastatic head/neck squamous cell carcinoma with disease
  • progression during platinum\-based chemotherapy who are planned for
  • pembrolizumab or other systemic therapies

Exclusion Criteria

  • ICI therapy in previous 12 months;
  • Suspected or confirmed viral, fungal, or bacterial infectious disease;
  • Use of immunosuppressive therapy prior to ICI start;
  • Estimated glomerular filtration rate (eGFR) \<30 mL/min/1\.73m2;
  • Known allergy to iodinated contrast agents;
  • Atrial fibrillation

Outcomes

Primary Outcomes

Not specified

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