Clinical trial · Observational
Multicenter Prospective Observational Study of Cardiotoxicity in Patients Receiving Targeted Cancer Therapies
Development of an Active Surveillance System for Adverse Reactions to Molecular Targeted Drugs Based on Biomarkers and Personalized Medicine and Its Impact on Patient Quality of Life
- 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 study will prospectively monitor cancer patients receiving chemotherapy (including molecular targeted therapies) for cardiovascular adverse events using biomarkers and imaging. The goal is to develop a predictive model for major adverse cardiovascular events (MACE) in this population by integrating both local factors (e.g. central venous catheter-related thrombosis) and systemic factors (e.g. age, comorbidities, genetic predisposition). An active surveillance system employing periodic cardiac evaluations (ECG, echocardiography) and biomarker measurements (troponin T, NT-proBNP) will enable early detection of cardiotoxic effects. The impact of these adverse events and the monitoring strategy on patients' quality of life will also be assessed.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer;Cardiovascular;Adverse Events | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Group 1: Patients with Cardiovascular Adverse Events (MACE Group).
- description
- Participants who experience one or more major adverse cardiovascular events during the study period. This case group will consist of all patients in the cohort who develop a new cardiovascular event (e.g., heart failure, arrhythmia, myocardial ischemia, thromboembolism, etc.) while undergoing chemotherapy or by the end of follow-up.
- label
- Group 2: Patients without Cardiovascular Adverse Events (No MACE Group).
- description
- Participants who do not experience any major cardiovascular adverse event during the study period. This control cohort includes patients from the same population (cancer patients on chemo/targeted therapy) who complete their treatment and follow-up without incident MACE. These patients will be frequency-matched by general characteristics such as age and sex to the MACE group for comparisons (all are adult Chinese patients with malignancy, no history of prior thrombotic events).
Primary outcomes (1)
- measure
- Incidence of New Onset Major Adverse Cardiovascular Events (MACE) by End of Chemotherapy
- timeFrame
- From initiation of chemotherapy to end of adjuvant chemotherapy (approximately up to 6 months per patient).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1.Adults (age \> 18 years) with a pathologically confirmed malignant tumor (any type of cancer); 2.Currently receiving or planning to receive chemotherapy (including regimens containing molecular targeted drugs) as adjuvant treatment for cancer; 3.Willing and able to participate in the study with provision of informed consent, and agreeable to provide required clinical data and biological samples. \- Exclusion Criteria: 1. Incomplete basic patient information or medical records (missing key data necessary for the study); 2. Failure to complete the full course of planned chemotherapy at the study center (e.g., patient did not adhere to or finish all cycles of adjuvant chemotherapy at our institution); 3. History of severe acute cardiovascular or cerebrovascular events within 6 months prior to enrollment, including acute heart failure, acute myocardial infarction, acute intracerebral hemorrhage (stroke), malignant arrhythmia, or New York Heart Association (NYHA) Class IV/V heart failure; 4. Missing essential pre- or post-chemotherapy evaluations: patients who did not undergo complete baseline or end-of-treatment assessments (such as blood routine, hepatic/renal function, coagulation profile, cardiac enzymes (troponin T), NT-proBNP (or BNP), 12-lead ECG, and echocardiogram)
References
Publications (0)
Data not yet available