Heart monitoring for cancer patients receiving chemotherapy and targeted drugs
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
This project will test whether regular heart checks (blood biomarkers, ECG, and echocardiogram) can predict serious heart problems in adults getting chemotherapy or targeted cancer drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab, bevacizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07058454 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational effort to monitor cardiac outcomes in adults undergoing chemotherapy or molecularly targeted cancer therapies. Participants will undergo periodic cardiac evaluations including ECG, echocardiography, and biomarker testing (troponin T, NT‑proBNP), with blood samples collected for genomic analysis. Local factors (for example, central venous catheter–related thrombosis) and systemic factors (age, comorbidities, BMI, genetic variants) will be integrated to develop a predictive model for major adverse cardiovascular events (MACE). The study will also track the impact of cardiotoxicity and the monitoring strategy on patients' quality of life.
Who should consider this trial
Good fit: Adults (≥18) with a pathologically confirmed cancer who are receiving or planning to receive chemotherapy or targeted cancer therapies and are willing to provide informed consent and biological samples.
Not a fit: Patients with recent severe cardiovascular or cerebrovascular events, incomplete medical records, or who cannot complete planned chemotherapy or follow-up at the study center are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the model could help detect heart damage earlier and guide personalized monitoring or treatment to reduce major cardiac events.
How similar studies have performed: Previous research has shown biomarkers like troponin and NT‑proBNP can detect early cardiotoxicity, but combining imaging, clinical and local catheter-related factors with genomics into a validated predictive model is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: xiaoyan li — Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: xiaoyan li
- Email: lixyan5@mail.sysu.edu.cn
- Phone: 13609066172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.