Cancer;Cardiovascular;Adverse EventsNCT07058454
Multicenter Prospective Observational Study of Cardiotoxicity in Patients Receiving Targeted Cancer Therapies
An observational study of Cancer;Cardiovascular;Adverse Events and Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study will prospectively monitor cancer patients receiving chemotherapy (including molecular targeted therapies) for cardiovascular adverse events using biomarkers and imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer;Cardiovascular;Adverse Events, Cancer
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adult cancer patients receiving adjuvant chemotherapy (including those receiving molecular targeted agents as part of therapy) at included centers (and collaborating centers) between June 1, 2025 and June 30, 2027. Eligible patients include those with any malignant solid tumor or hematologic malignancy who are starting a planned course of postoperative (adjuvant) chemotherapy. Enrollment will be consecutive and non-selective - all patients meeting inclusion criteria (and no exclusion criteria) in the participating centers during the accrual window will be invited to participate. Patients are typically enrolled at the time of initiation of chemotherapy, with baseline cardiovascular assessments performed prior to or at the first cycle of treatment. The cohort will be followed prospectively through their chemotherapy course and for up to 6 months after completion of therapy.
Who may be able to join
- 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.
- -
Who cannot join
- Incomplete basic patient information or medical records (missing key data necessary for the study);
- 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);
- 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;
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 5106555
xiaoyan li, 13609066172, lixyan5@mail.sysu.edu.cn
About this study
Official title: 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 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.
Read the detailed description
Cancer patients are at heightened risk of cardiovascular complications due to both their disease and its treatments. Many chemotherapeutic and targeted agents (e.g. anthracyclines, trastuzumab, bevacizumab, tyrosine kinase inhibitors) carry cardiotoxic potential, leading to diverse manifestations of MACE such as heart failure, arrhythmias, ischemic heart disease, valvular dysfunction, hypertension, thromboembolism, and others. As cancer survival improves and newer therapies are widely used, the incidence of treatment-related cardiac toxicity continues to rise. Early cardiotoxic changes are often subclinical, making proactive monitoring essential. Research has shown that cardiac biomarkers can rise before left ventricular ejection fraction declines, enabling "pre-symptomatic" detection of cardiotoxicity. By quantitatively analyzing the predictive value of each indicator for MACE, the study aims to construct a comprehensive risk prediction model for precise cardiovascular risk evaluation in cancer patients. Both local risk factors (e.g., indwelling catheter-related thrombosis) and systemic factors (e.g., age, hypercoagulability, body mass index) will be incorporated, reflecting the interplay of factors contributing to MACE. Genetic biomarkers will also be explored: blood samples are collected for genomic analysis (such as SNP genotyping and whole genome sequencing) to identify genetic polymorphisms associated with increased susceptibility to therapy-related MACE. By comparing patients who develop cardiovascular events to those who do not, we will characterize the incidence, timing, affected organs, and clinical presentation of MACE in cancer patients. Patient-reported quality of life will be evaluated using validated questionnaires, to determine how the occurrence of adverse cardiovascular events (and the implementation of active monitoring) affects daily functioning and overall well-being. Ultimately, this study's findings will provide a scientific basis for individualized risk stratification and preventive interventions in cardio-oncology, supporting optimized clinical strategies to mitigate cardiovascular risk without compromising effective cancer treatment.
- Conditions
- Cancer;Cardiovascular;Adverse Events, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients with Cardiovascular Adverse Events (MACE Group). | 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. | |
| Group 2: Patients without Cardiovascular Adverse Events (No MACE Group). | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New Onset Major Adverse Cardiovascular Events (MACE) by End of Chemotherapy
Occurrence of any new cardiovascular adverse event from start of chemotherapy to the completion of the chemotherapy regimen. "MACE" is defined per ESC guidelines to include major cardiac events such as new myocardial dysfunction, symptomatic heart failure, coronary artery disease (e.g. myocardial infarction), clinically significant valvular disease, arrhythmia (e.g. atrial fibrillation), new or worsening hypertension, thromboembolic events (including deep vein thrombosis or pulmonary embolism), peripheral vascular disease, pulmonary hypertension, or pericardial disease. Any such event recorded on electrocardiogram, cardiac ultrasound (echocardiography), or via cardiac enzymes (troponin T) and biomarkers (NT-proBNP/BNP) by the end of the adjuvant chemotherapy cycle, relative to the patient's pre-treatment baseline, will be counted as an outcome event. (Early cardiovascular events are defined as those occurring during the chemotherapy period.)
Measured: From initiation of chemotherapy to end of adjuvant chemotherapy (approximately up to 6 months per patient).
Secondary outcomes (1)
Quality of Life Score Change (Baseline to 6 Months Post-treatment)
Change in patient-reported quality of life from baseline (pre-therapy) to follow-up after therapy completion. Quality of life will be measured using a validated questionnaire (e.g., EORTC QLQ-C30 or similar cancer-specific QoL instrument) at study entry and at 6 months after the last chemotherapy cycle. The difference in global health/QoL scores and functional subscales will be analyzed to determine the impact of any adverse events and the monitoring program on patients' quality of life.
Measured: Baseline pre-therapy and 6 months after completion of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer;Cardiovascular;Adverse EventsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaoyan li, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058454
- Sponsor's protocol ID
- 2024ZSLYEC-667
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07058454
- Acronym / sponsor ID
- 2024ZSLYEC-667
- Conditions
- Cancer;Cardiovascular;Adverse Events, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cancer patients are at heightened risk of cardiovascular complications due to both their disease and its treatments. Many chemotherapeutic and targeted agents (e.g. anthracyclines, trastuzumab, bevacizumab, tyrosine kinase inhibitors) carry cardiotoxic potential, leading to diverse manifestations of MACE such as heart failure, arrhythmias, ischemic heart disease, valvular dysfunction, hypertension, thromboembolism, and others. As cancer survival improves and newer therapies are widely used, the incidence of treatment-related cardiac toxicity continues to rise. Early cardiotoxic changes are often subclinical, making proactive monitoring essential. Research has shown that cardiac biomarkers can rise before left ventricular ejection fraction declines, enabling "pre-symptomatic" detection of cardiotoxicity. By quantitatively analyzing the predictive value of each indicator for MACE, the study aims to construct a comprehensive risk prediction model for precise cardiovascular risk evaluation in cancer patients. Both local risk factors (e.g., indwelling catheter-related thrombosis) and systemic factors (e.g., age, hypercoagulability, body mass index) will be incorporated, reflecting the interplay of factors contributing to MACE. Genetic biomarkers will also be explored: blood samples are collected for genomic analysis (such as SNP genotyping and whole genome sequencing) to identify genetic polymorphisms associated with increased susceptibility to therapy-related MACE. By comparing patients who develop cardiovascular events to those who do not, we will characterize the incidence, timing, affected organs, and clinical presentation of MACE in cancer patients. Patient-reported quality of life will be evaluated using validated questionnaires, to determine how the occurrence of adverse cardiovascular events (and the implementation of active monitoring) affects daily functioning and overall well-being. Ultimately, this study's findings will provide a scientific basis for individualized risk stratification and preventive interventions in cardio-oncology, supporting optimized clinical strategies to mitigate cardiovascular risk without compromising effective cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients with Cardiovascular Adverse Events (MACE Group). | – | –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. |
| Group 2: Patients without Cardiovascular Adverse Events (No MACE Group). | – | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult cancer patients receiving adjuvant chemotherapy (including those receiving molecular targeted agents as part of therapy) at included centers (and collaborating centers) between June 1, 2025 and June 30, 2027. Eligible patients include those with any malignant solid tumor or hematologic malignancy who are starting a planned course of postoperative (adjuvant) chemotherapy. Enrollment will be consecutive and non-selective - all patients meeting inclusion criteria (and no exclusion criteria) in the participating centers during the accrual window will be invited to participate. Patients are typically enrolled at the time of initiation of chemotherapy, with baseline cardiovascular assessments performed prior to or at the first cycle of treatment. The cohort will be followed prospectively through their chemotherapy course and for up to 6 months after completion of therapy.
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (4 listed)
- Incomplete basic patient information or medical records (missing key data necessary for the study);
- 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);
- 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;
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of New Onset Major Adverse Cardiovascular Events (MACE) by End of Chemotherapy
Time frame: From initiation of chemotherapy to end of adjuvant chemotherapy (approximately up to 6 months per patient).
Occurrence of any new cardiovascular adverse event from start of chemotherapy to the completion of the chemotherapy regimen. "MACE" is defined per ESC guidelines to include major cardiac events such as new myocardial dysfunction, symptomatic heart failure, coronary artery disease (e.g. myocardial infarction), clinically significant valvular disease, arrhythmia (e.g. atrial fibrillation), new or worsening hypertension, thromboembolic events (including deep vein thrombosis or pulmonary embolism), peripheral vascular disease, pulmonary hypertension, or pericardial disease. Any such event recorded on electrocardiogram, cardiac ultrasound (echocardiography), or via cardiac enzymes (troponin T) and biomarkers (NT-proBNP/BNP) by the end of the adjuvant chemotherapy cycle, relative to the patient's pre-treatment baseline, will be counted as an outcome event. (Early cardiovascular events are defined as those occurring during the chemotherapy period.)
1 secondary outcome
Quality of Life Score Change (Baseline to 6 Months Post-treatment)
Time frame: Baseline pre-therapy and 6 months after completion of chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer;Cardiovascular;Adverse Events
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
xiaoyan li principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer;Cardiovascular;Adverse Events and Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaoyan li (13609066172, lixyan5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New Onset Major Adverse Cardiovascular Events (MACE) by End of Chemotherapy (time frame: From initiation of chemotherapy to end of adjuvant chemotherapy (approximately up to 6 months per patient).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.