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

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).

Study Overview

• Status: Recruiting
• Conditions: Metabolic Disorder; Cardiac Insufficiency; Oncologic Complications; Cardiac Complication; Cardiovascular Complication; Cardiovascular Insufficiency; Cardiac Disorder; Vascular Disorder
• Intervention / Treatment: Drug: Anti-Cancer Agents

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Stéphane Edehry, MD; Phone Number: +33 (0)1 49 28 24 59; Email: stephane.edehry@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
  • Paris, France, 75012
    • Recruiting
    • AP-HP, Saint-Antoine Hospital, Department of cardiology
    • Contact: Edehry Stephane, MD; Phone Number: +33 (0)1 49 28 24 59; Email: stephane.edehry@aphp.fr
  • Paris, France, 75020
    • Recruiting
    • AP-HP, Tenon Hospital, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering (or having suffered) from a cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients having a benefit after this specific cardio-oncology check up and follow up	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments	5 years
All relevants staisticals associations between adverse events and anticancer drugs	5 years
All relevant statistical associations between cardiovascular toxicities, and anticancer drugs	5 years
All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments	5 years
All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival	5 years
All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments	5 years
All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival	5 years
All relevant statistical associations between the pre therapeutic cardiovascular checkup and follow up for patients with cancer or history of cancer, and the occurence of cardiovascular toxicities of oncology treatments.	5 years
All relevant statistical associations between metabolic toxicities, and anticancer drugs	5 years
All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments	5 years
All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival	5 years
All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments	5 years
All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival	5 years
All relevant statistical associations between the pre therapeutic metabolic checkup and follow up for patients with cancer or history of cancer, and the occurence of metabolic toxicities of oncology treatments.	5 years

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: adverse drug reactions; anticancer drugs; cardiovascular prevention; cardiac toxicities; vascular toxicities; metabolic toxicities
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Heart Failure; Heart Diseases; Disease; Vascular Diseases; Metabolic Diseases; Cardiotoxicity; Antineoplastic Agents
• Other Study ID Numbers: CIC1421-19-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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.: Yes