NCT07058454 Multicenter Prospective Observational Study of Cardiotoxicity in Patients Receiving Targeted Cancer Therapies
| NCT ID | NCT07058454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Cancer;Cardiovascular;Adverse Events |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2025-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
xiaoyan li
PRINCIPAL INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT07058454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer;Cardiovascular;Adverse Events. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07058454 currently recruiting?
Yes, NCT07058454 is actively recruiting participants. Contact the research team at lixyan5@mail.sysu.edu.cn for enrollment information.
Where is the NCT07058454 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07058454 clinical trial?
NCT07058454 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The principal investigator is xiaoyan li at Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 5,000 participants.
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