Cardiovascular DiseasesPARCANCT06409481
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)
An observational study of Cardiovascular Diseases and Cardiac Diseases, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Diseases, Vascular Diseases
- What is being tested?
- Antineoplastic Agents
- How many people
- 800,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been treated with an antineoplastic agent and have been diagnosed with tumors that represent advanced non-small cell lung cancer.
Who may be able to join
- Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
- Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
- Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
- The number of reports corresponding to each drug or adverse event is at least three.
- The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.
Who cannot join
- Any of the information in the baseline information such as gender, age, region, date of report is empty.
- The severity level of the reported adverse event is empty.
- Adverse events were reported in patients whose drug indications included cardiovascular disease.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.
Read the detailed description
Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).
- Conditions
- Cardiovascular Diseases, Cardiac Diseases, Vascular Diseases, Cancer
- Being tested
- Antineoplastic Agents
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Vascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antineoplastic AgentsDrug
small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics
| Study group | Role | What they receive |
|---|---|---|
| Adverse Events with Antineoplastic agents | Cases reported in VigiBase, FAERS and other pharmacovigilance databases of patients treated by antineoplastic agents, with a chronology compatible with the drug toxicity. Receives: Drug: Antineoplastic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-vascular toxicity of antineoplastic agents
Identification and report of the cardio-vascular toxicity of antineoplastic agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT). Drugs investigated are antineoplastic agents.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Secondary outcomes (7)
Causality assessment of reported cardiovascular events according to pharmacovigilance databases
Disproportionality individual case data analysis between cardiovascular events and antineoplastic agents.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors.
Cardiovascular events are identified using MedDRA terms. Each cardiovascular event and risk factor will be assessed for potential over-reporting by calculating odds ratios. Factors evaluated will include, but are not limited to, cancer type and patient baseline characteristics (gender, age, country of reporting, etc.). Additionally, the year of reporting and other relevant variables will be considered.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assess cardiovascular toxicity differences among antineoplastic agent classes and within the same class.
The data were classified into different drug classes based on the Anatomical Therapeutic Chemical (ATC) classification system. This included small molecule kinase inhibitors, immune checkpoint inhibitors, and monoclonal antibodies. The occurrence of major adverse events was identified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The differences in cardiovascular toxicity between drug classes were evaluated using disproportionality analysis (single drug vs. full database). To assess toxicity differences between drugs in the same class, for example, a comparison could be made between the cardiovascular toxicity of drugs such as erlotinib, afatinib, and osimertinib, which all belong to the category of EGFR tyrosine kinase inhibitors. Disproportionality analyses (single drug vs. other drugs in the same class) were employed in this regard.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assessment of the severity of cardiovascular toxicity associated with antineoplastic agents
Reports with fatal outcomes will be compared with reports without fatal outcomes. Odds ratio will be calculated to compare covariates that may be associated with an increased risk of death, including type of adverse cardiovascular event, type of cancer reported, age of the patient, gender, comorbidities, and antitumor monotherapy or combination therapy.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
The analysis includes analyzing the relationship between the duration of treatment and the occurrence of toxicity, taking into account the cumulative dose of the administered medication.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the drug-drug interactions associated with adverse events.
Describe cardiovascular adverse events reported when two or more drugs are taken concurrently or consecutively in patients with the same indication.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the population of patients having a cardio-vascular adverse events
The patient population with cardiovascular adverse events was described in terms of baseline information, including patient indication, age, sex, country of reporting origin, and clinical outcomes, among other factors.
Measured: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 800,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaohong Kang, PhD, Study director, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409481
- Sponsor's protocol ID
- EC-024-092
- Acronym
- PARCA
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)
- ClinicalTrials.gov ID
- NCT06409481
- Acronym / sponsor ID
- PARCA / EC-024-092
- Conditions
- Cardiovascular Diseases, Cardiac Diseases, Vascular Diseases, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 10 May 2024 (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.
The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.
Detailed description
Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adverse Events with Antineoplastic agents | – | Drug: Antineoplastic AgentsCases reported in VigiBase, FAERS and other pharmacovigilance databases of patients treated by antineoplastic agents, with a chronology compatible with the drug toxicity. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been treated with an antineoplastic agent and have been diagnosed with tumors that represent advanced non-small cell lung cancer.
Key inclusion criteria (5 listed)
- Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
- Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
- Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
- The number of reports corresponding to each drug or adverse event is at least three.
- The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.
Key exclusion criteria (3 listed)
- Any of the information in the baseline information such as gender, age, region, date of report is empty.
- The severity level of the reported adverse event is empty.
- Adverse events were reported in patients whose drug indications included cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antineoplastic Agentssmall-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics | Drug | Adverse Events with Antineoplastic agents |
Primary outcome
Cardio-vascular toxicity of antineoplastic agents
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Identification and report of the cardio-vascular toxicity of antineoplastic agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT). Drugs investigated are antineoplastic agents.
7 secondary outcomes
Causality assessment of reported cardiovascular events according to pharmacovigilance databases
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors.
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assess cardiovascular toxicity differences among antineoplastic agent classes and within the same class.
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Assessment of the severity of cardiovascular toxicity associated with antineoplastic agents
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the drug-drug interactions associated with adverse events.
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Description of the population of patients having a cardio-vascular adverse events
Time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiaohong Kang, PhD study director
First Affiliated Hospital of Xinjiang Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiac Diseases, run by The First Affiliated Hospital of Xinxiang Medical College.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohong Kang, PhD (+86-13938756036, 1fy2014036@xxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardio-vascular toxicity of antineoplastic agents (time frame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024). 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 10 May 2024.