Who is sponsoring NCT03530215?

NCT03530215 is sponsored by Groupe Hospitalier Pitie-Salpetriere.

What drugs are being tested in NCT03530215?

Interventions in NCT03530215: Antineoplastic and Immunomodulating Agents.

What condition does NCT03530215 study?

NCT03530215 studies Cardiac Disease, Cancer.

Is NCT03530215 still recruiting?

NCT03530215 is currently completed. Last updated 13 April 2023.

Last reviewed 2023-04-13 · How we verify

NCT03530215: EROCA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 13 April 2023

What this trial tests

trial testing Antineoplastic and Immunomodulating Agents in Cardiac Disease in 500,000 participants. Completed in 8 April 2023.

Timeline

2 May 2018

Primary endpoint
1 May 2022

8 April 2023

Quick facts

Lead sponsor	Groupe Hospitalier Pitie-Salpetriere
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500,000
Start date	2 May 2018
Primary completion	1 May 2022
Estimated completion	8 April 2023
Sites	1 location across France

Drugs / interventions tested

Antineoplastic and Immunomodulating Agents — full drug profile →

Conditions studied

Cardiac Disease — all drugs for Cardiac Disease →
Cancer — all drugs for Cancer →

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Who can join

Adults 0 to 100, any sex, with Cardiac Disease or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Cardiovascular Toxicities Associated With Ibrutinib.
Salem JE, Manouchehri A, Bretagne M, Lebrun-Vignes B, et al · · 2019 · cited 203× · PMID 31558250 · DOI 10.1016/j.jacc.2019.07.056
Ibrutinib-Mediated Atrial Fibrillation Attributable to Inhibition of C-Terminal Src Kinase.
Xiao L, Salem JE, Clauss S, Hanley A, et al · · 2020 · cited 183× · PMID 33092403 · DOI 10.1161/circulationaha.120.049210
Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study.
Salem JE, Nguyen LS, Moslehi JJ, Ederhy S, et al · · 2021 · cited 57× · PMID 34370839 · DOI 10.1093/eurheartj/ehab362
Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database.
Alexandre J, Salem JE, Moslehi J, Sassier M, et al · · 2021 · cited 52× · PMID 32353110 · DOI 10.1093/ehjcvp/pvaa037
Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study.
Hilmi M, Ederhy S, Waintraub X, Funck-Brentano C, et al · · 2020 · cited 23× · PMID 33096756 · DOI 10.3390/ph13100325
Sipuleucel-T associated inflammatory cardiomyopathy: a case report and observations from a large pharmacovigilance database.
Moey MYY, Jiwani RA, Takeda K, Prenshaw K, et al · · 2021 · cited 6× · PMID 33938158 · DOI 10.1002/ehf2.13400

Verify or expand the search:

Other trials of Antineoplastic and Immunomodulating Agents

Trials testing the same drug.

NCT04696250 — Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR) · unknown

Other recruiting trials for Cardiac Disease

Currently open trials in the same condition.

NCT07532174 — Efferon LPS Hemoadsorption in Cardiac Surgery Patients · NA · recruiting
NCT06294119 — Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay · NA · recruiting
NCT07274436 — The Clinical Value of Deep Learning-Based Reconstruction Techniques in Cardiac MRI Scanning · recruiting
NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting
NCT05877755 — Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging · NA · recruiting

Other Groupe Hospitalier Pitie-Salpetriere trials

Trials by the same sponsor.

NCT06515678 — Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension · active not recruiting
NCT05934214 — EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Databa · completed
NCT05819736 — Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients · unknown
NCT04320017 — Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observa · completed
NCT04314817 — Adverse Events Related to Treatments Used Against Coronavirus Disease 2019 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03530215 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Groupe Hospitalier Pitie-Salpetriere
Last refreshed: 13 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03530215.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing