Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

NCT ID: NCT03882580

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2025-03-01

Brief Summary

Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

Detailed Description

Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

Conditions

Cardiovascular Complication; Cardiovascular Insufficiency; Cardiac Complication; Oncologic Complications; Cardiac Insufficiency; Metabolic Disorder; Vascular Disorder; Cardiac Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Anti-Cancer Agents

Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Suffering a cancer
• Evaluated within a cardio-oncology program

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: lead

Responsible Party

Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AP-HP, Saint-Antoine Hospital, Department of cardiology

Paris, , France

Site Status: RECRUITING

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

Paris, , France

Site Status: RECRUITING

AP-HP, Tenon Hospital, Department of Cardiology

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Joe-Elie Salem, MD, PhD

Role: CONTACT

joe-elie.salem@aphp.fr

(0)1 42 17 85 33 ext. +33

Stéphane Edehry, MD

Role: CONTACT

stephane.edehry@aphp.fr

(0)1 49 28 24 59 ext. +33

Facility Contacts

Edehry Stephane, MD

Role: primary

stephane.edehry@aphp.fr

(0)1 49 28 24 59 ext. +33

Joe-Elie Salem, Md, PhD

Role: primary

joe-elie.salem@aphp.fr

(0)1 42 17 85 33 ext. +33

References

Salem JE, Allenbach Y, Vozy A, Brechot N, Johnson DB, Moslehi JJ, Kerneis M. Abatacept for Severe Immune Checkpoint Inhibitor-Associated Myocarditis. N Engl J Med. 2019 Jun 13;380(24):2377-2379. doi: 10.1056/NEJMc1901677. No abstract available.

Reference Type: BACKGROUND

PMID: 31189043 (View on PubMed)

Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1):e000261. doi: 10.1136/jitc-2019-000261.

Reference Type: DERIVED

PMID: 31988143 (View on PubMed)

Other Identifiers

CIC1421-19-05

Identifier Type: -

Identifier Source: org_study_id