Clinical trial · Observational
Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia
NCT04541212CI-TRIAL-00091066CarChemactive not recruitingClinicalTrials.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)
This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations. Safety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac Imaging | Diagnostic Test | — | UNRESOLVED |
| Data Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Prospective
- interventionNames
- Diagnostic Test: Cardiac Imaging
- label
- Cohort B
- description
- Retrospective/Prospective
- interventionNames
- Diagnostic Test: Cardiac Imaging
- Other: Data Collection
Primary outcomes (2)
- measure
- Myocardial extracellular volume (ECV)
- timeFrame
- Change from baseline to 3, 6, 12,and 24 months
- description
- Cohort A
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older at time of CT initiation * Signed informed consent * Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects) * Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline * Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy * The participant is willing to undergo CMR scans and all other required study procedures Exclusion Criteria: * Known cardiomyopathy and/or LVEF \<50% * Known heart failure * History of myocardial infarction (MI) * Clinically significant cardiac valvular disease * Clinically significant pericardial effusion * Allografted subjects * Contraindications to CMR testing (Cohort A \& prospective evaluation for Cohort B): * Pacemakers, other metallic implants or severe claustrophobia * Weight \> 135 kg * Patients with a history of previous allergic reaction to gadolinium * Patients with history of seizure * Renal insufficiency (eGFR of \< 45ml/min/1.73m2 using the MDRD equation) * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available
No reference posted for this study.