Cardiac DiseaseEROCANCT03530215

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

An observational study of Cardiac Disease and Cancer, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 0 to 100 years
Conditions the study is for: Cardiac Disease, Cancer
What is being tested?: Antineoplastic and Immunomodulating Agents
How many people: 500,000 participants
Where: 1 siteFrance
Study dates: 2 May 2018to 8 Apr 2023
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 0 to 100 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients treated with Antineoplastic and immunomodulating agents

Who may be able to join

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.

Who cannot join

Chronology not compatible between the drug and the toxicity

Trial locations and contacts

1 site in 1 country.

France1 site

AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, 75013

Other trials in France

About this study

Read the 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

Conditions: Cardiac Disease, Cancer
Being tested: Antineoplastic and Immunomodulating Agents
Keywords: Cardiotoxicity, Antineoplastic and immunomodulating agents
Medical subject headings: Heart Diseases, Neoplasms, Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Antineoplastic and Immunomodulating AgentsDrug
Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Study groups in NCT03530215
Study group	Role	What they receive
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 Receives: Drug: Antineoplastic and Immunomodulating Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Causality assessment of reported cardiovascular events according to the WHO system
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
Description of the type of cardiotoxicity depending on the category of antineoplastic and immunomodulating agents
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
Description of the duration of treatment when the toxicity happens
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
Description of the drug-drug interactions associated with adverse events
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
Description of the population of patients having a cardio-vascular adverse event
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20188 Apr 2023

First posted21 May 2018
Study start2 May 2018
Primary completion1 May 2022
Study completion8 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cardiac DiseaseStudies 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: 500,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03530215
Sponsor's protocol ID: CIC1421-18-12
Acronym: EROCA
Status last verified: Apr 2023
First submitted: 8 May 2018
Last updated: 13 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Salem JE, Nguyen LS, Moslehi JJ, Ederhy S, Lebrun-Vignes B, Roden DM, Funck-Brentano C, Gougis P. Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study. Eur Heart J. 2021 Oct 7;42(38):3915-3928. doi: 10.1093/eurheartj/ehab362.
PubMed 34370839
Xiao L, Salem JE, Clauss S, Hanley A, Bapat A, Hulsmans M, Iwamoto Y, Wojtkiewicz G, Cetinbas M, Schloss MJ, Tedeschi J, Lebrun-Vignes B, Lundby A, Sadreyev RI, Moslehi J, Nahrendorf M, Ellinor PT, Milan DJ. Ibrutinib-Mediated Atrial Fibrillation Attributable to Inhibition of C-Terminal Src Kinase. Circulation. 2020 Dec 22;142(25):2443-2455. doi: 10.1161/CIRCULATIONAHA.120.049210. Epub 2020 Oct 23.
PubMed 33092403
Salem JE, Ederhy S, Lebrun-Vignes B, Moslehi JJ. Cardiac Events Associated With Chimeric Antigen Receptor T-Cells (CAR-T): A VigiBase Perspective. J Am Coll Cardiol. 2020 May 19;75(19):2521-2523. doi: 10.1016/j.jacc.2020.02.070. No abstract available.
PubMed 32408984
Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
PubMed 32353110
Salem JE, Manouchehri A, Bretagne M, Lebrun-Vignes B, Groarke JD, Johnson DB, Yang T, Reddy NM, Funck-Brentano C, Brown JR, Roden DM, Moslehi JJ. Cardiovascular Toxicities Associated With Ibrutinib. J Am Coll Cardiol. 2019 Oct 1;74(13):1667-1678. doi: 10.1016/j.jacc.2019.07.056.
PubMed 31558250

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)
ClinicalTrials.gov ID: NCT03530215
Acronym / sponsor ID: EROCA / CIC1421-18-12
Conditions: Cardiac Disease, Cancer
Keywords: Cardiotoxicity, Antineoplastic and immunomodulating agents
Study type: Observational
Recruitment status: Completed
Enrolment: 500,000 participants (actual)
Lead sponsor: Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
Study start: 2 May 2018 (actual)
Primary completion: 1 May 2022 (actual)
Study completion: 8 Apr 2023 (actual)
First posted: 21 May 2018 (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.

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Adverse Events with Antineoplastic and immunomodulating agents	–	Drug: Antineoplastic and Immunomodulating AgentsCases 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

Who may qualify

Ages: 0 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients treated with Antineoplastic and immunomodulating agents

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

Chronology not compatible between the drug and the toxicity

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 and Immunomodulating AgentsAntineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L	Drug	Adverse Events with Antineoplastic and immunomodulating agents

Primary outcome

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)

6 secondary outcomes

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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Derived from this study: PubMed 34370839Salem JE, Nguyen LS, Moslehi JJ, Ederhy S, Lebrun-Vignes B, Roden DM, Funck-Brentano C, Gougis P. Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study. Eur Heart J. 2021 Oct 7;42(38):3915-3928. doi: 10.1093/eurheartj/ehab362.
Derived from this study: PubMed 33092403Xiao L, Salem JE, Clauss S, Hanley A, Bapat A, Hulsmans M, Iwamoto Y, Wojtkiewicz G, Cetinbas M, Schloss MJ, Tedeschi J, Lebrun-Vignes B, Lundby A, Sadreyev RI, Moslehi J, Nahrendorf M, Ellinor PT, Milan DJ. Ibrutinib-Mediated Atrial Fibrillation Attributable to Inhibition of C-Terminal Src Kinase. Circulation. 2020 Dec 22;142(25):2443-2455. doi: 10.1161/CIRCULATIONAHA.120.049210. Epub 2020 Oct 23.
Derived from this study: PubMed 32408984Salem JE, Ederhy S, Lebrun-Vignes B, Moslehi JJ. Cardiac Events Associated With Chimeric Antigen Receptor T-Cells (CAR-T): A VigiBase Perspective. J Am Coll Cardiol. 2020 May 19;75(19):2521-2523. doi: 10.1016/j.jacc.2020.02.070. No abstract available.
Derived from this study: PubMed 32353110Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
Derived from this study: PubMed 31558250Salem JE, Manouchehri A, Bretagne M, Lebrun-Vignes B, Groarke JD, Johnson DB, Yang T, Reddy NM, Funck-Brentano C, Brown JR, Roden DM, Moslehi JJ. Cardiovascular Toxicities Associated With Ibrutinib. J Am Coll Cardiol. 2019 Oct 1;74(13):1667-1678. doi: 10.1016/j.jacc.2019.07.056.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Cardiac Disease and Cancer, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 2023. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03530215, which also lists 5 linked publications.

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 13 Apr 2023.