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

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ClinicalTrials.gov Identifier: NCT03530215
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

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
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

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : September 1, 2022

Group/Cohort 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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Antineoplastic and immunomodulating agents
Criteria

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 L.

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530215


Contacts
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Contact: Joe-elie SALEM, MD PHD (0)142178533 ext +33 joe-elie.salem@aphp.fr

Locations
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France
AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM. Recruiting
Paris, France, 75013
Contact: Joe-Elie SALEM, MD-PHD    (0)142178533 ext +33    joe-elie.salem@aphp.fr   
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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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, Groupe Hospitalier Pitie-Salpetriere:
Cardiotoxicity
Antineoplastic and immunomodulating agents
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Antineoplastic Agents