Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)

• Sponsor: Groupe Hospitalier Pitie-Salpetriere (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03530215
• Collaborator: (none)
• Enrollment: 500,000
• Location: 1
• Anticipated Duration (Months): 52
• Patients Per Site Per Month: 9613.9

Study Details

Study Description

Brief Summary

Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse reactions. This study investigates reports of cardio-vascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease; Cancer	Drug: Antineoplastic and Immunomodulating Agents

Detailed Description

Antineoplastic therapies are responsible of a wide range of cardio-vascular side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reactions following treatment with antineoplastic and immunomodulating agents

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500000 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)
• Actual Study Start Date: May 2, 2018
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Adverse Events with Antineoplastic and immunomodulating agents Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Antineoplastic and immunomodulating agents, with a chronology compatible with the drug toxicity	Drug: Antineoplastic and Immunomodulating Agents; Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Outcome Measures

Primary Outcome Measures

1. Cardio-vascular toxicity of antineoplastic and immunomodulating agents [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

   Identification and report of cardio-vascular toxicities of antineoplastic and immunomodulating agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT)

Secondary Outcome Measures

1. Causality assessment of reported cardiovascular events according to the WHO system [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

2. Description of the type of cardiotoxicity depending on the category of antineoplastic and immunomodulating agents [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

3. Description of the duration of treatment when the toxicity happens [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

4. Description of the drug-drug interactions associated with adverse events [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

5. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

6. Description of the population of patients having a cardio-vascular adverse event [Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 30/04/2018

• Adverse events reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)

• Patients treated with Antineoplastic and immunomodulating agents included in the ATC

Exclusion Criteria:

• Chronology not compatible between the drug and the toxicity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.	Paris		France	75013

Sponsors and Collaborators

• Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere
• ClinicalTrials.gov Identifier: NCT03530215
• Other Study ID Numbers: CIC1421-18-12
• First Posted: May 21, 2018
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere: Cardiotoxicity; Antineoplastic and immunomodulating agents
• Additional relevant MeSH terms: Heart Diseases; Antineoplastic Agents

Study Results

No Results Posted as of Sep 4, 2019