Clinical trial · Observational
Development of a Pharmacogenomic Panel for Early Detection of Chemotherapy- and Immunotherapy-Induced Cardiotoxicity.
NCT07663357CI-TRIAL-00115657recruitingClinicalTrials.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)
To evaluate the use of a pharmacogenetic and pharmacoepigenetic panel for predicting chemotherapy- and immunotherapy-induced cardiotoxicity in cancer patients.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Discovery cohort with cardiotoxicity
- description
- This cohort will consist of participants with cardiotoxicity after one year of treatment and will be used for exome analysis and miRNA sequencing. In this cohort, metabolomic and proteomic profiling, drug concentration measurements, and assessments of immune function and inflammation will also be be performed.
- label
- Validation cohort with cardiotoxicity
- description
- This cohort will consist of participants with cardiotoxicity after one year of treatment and will be used to validate the genetic variants identified through exome analysis, as well as the miRNAs selected following sequencing.
- label
- Discovery cohort without cardiotoxicity
- description
- This cohort will consist of participants without cardiotoxicity after one year of treatment and will be used for exome analysis and miRNA sequencing. In this cohort, metabolomic and proteomic profiling, drug concentration measurements, and assessments of immune function and inflammation will also be be performed.
- label
- Validation cohort without cardiotoxicity
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a confirmed diagnosis of breast cancer who are scheduled to initiate treatment with anthracyclines and/or HER2-targeted therapies (anti-HER2 therapies). Exclusion Criteria: * Patients with a left ventricular ejection fraction (LVEF) \< 50%; * Patients who have undergone chemotherapy and/or radiotherapy within the previous year; * Patients with chronic kidney disease and a glomerular filtration rate (GFR) \< 30 mL/min/1.73 m²; * Patients with uncontrolled hypertension; * Patients with complex congenital heart disease.
References
Publications (0)
Data not yet available
No reference posted for this study.