Clinical trial · Observational
Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
NCT05159479CI-TRIAL-00069799unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Incidence of fluoropyrimidine induced cardiotoxicity (FIC)
- timeFrame
- 12 months
- description
- Fluoropyrimidine induced cardiotoxicity defined as a composite of: * Types 1-3 myocardial infarction with troponin \>99th percentile upper limit, * Incident myocardial ischaemia (chest pain with or without new inducible perfusion abnormality on perfusion cardiac MRI, * Myocarditis (diagnosed as per European Society of Cardiology Consensus statement) * Incident heart failure (HF) diagnosis (symptoms with raised N-terminal pro-B-type natriuretic peptide (NTproBNP )\> 400pg/ml or HF hospitalisation), * Incident arrhythmia (excluding isolated ectopy) or sudden cardiac death.
- measure
- Relationship of baseline cardiovascular risk with FIC
- timeFrame
- 12 months
- description
- Baseline cardiovascular risk assessed using QRISK3 cardiovascular risk calculator
- measure
- Relationship of baseline cardiovascular risk with FIC
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 * Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic) * Capacity to provide consent Exclusion Criteria: * Age \<18 * Lacking capacity to consent
References
Publications (0)
Data not yet available
No reference posted for this study.