Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. (PICARO)

Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort

Recently, the medical management of cancer patients has considerably improved the prognosis of these patients and today some cancers are becoming "chronic diseases". As a result, new adverse effects (AEs) are observed, particularly cardiac.

These "new" cardiac AEs are the consequence of a significant increase in patients life expectancy (delayed AEs not previously seen) but also the use of new pharmacological classes of anticancer drugs such as kinase inhibitors. The incidence of these cardiac AEs varies according to the patient profile and the anticancer molecules used, but their impact on the morbidity and mortality of the patients is significant.

In this context, we started at the University Hospital of Caen Normandy in September 2017 a cardio-oncology program entitled "prevention and pharmacological management of cardiac adverse effects induced by drugs used in Oncology" (PICARO program). This program involves the pharmacology department (opening of a dedicated consultation), the cardiology department (opening of a dedicated ultrasound consultation), vascular medicine departement (opening of a dedicated consultation) and the oncology federation. This program aims to be regional in the future. We therefore propose to build a cohort backed up to the PICARO program to assess the regional impact of cardiac AEs of anticancer drugs and thus to be better able to specify the number of AEs, the incidence and regional prevalence of these drugs. .

The constitution of this cohort is only the first step towards the constitution in the near future (2 years) of an observatory and then a regional registry of cardiac AEs induced by anticancer drugs. The objectives associated with the establishment of such a registry would be to reduce the number of cardiac AEs, the hospitalizations caused by these AEs, a better information of health professionals and patients, an improvement in the screening of patients at risk, all coming back in the context of health, clinical, epidemiological and pharmacological surveillance.

Study Overview

• Status: Unknown
• Conditions: Cardio-oncology
• Intervention / Treatment: Other: observational cohort with plasma samples

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • Recruiting
      • CHU caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All cancer patients presenting the eligibility criteria referred to the PICARO program

Description

Inclusion Criteria:

• Patient ≥ 18 years,
• Attents of cancer,
• Addressed for the first time to one of the PICARO program consultations at the University Hospital of Caen Normandy,
• Written informed consent,
• Patient beneficiary of the french social insurance.

Exclusion Criteria:

• Minor and major protected patients
• pregnant or nursing women
• patient already included in the PICARO cohort
• Patients under guardianship, curatorship, safeguard of justice or legal protection.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational cohort with plasma samples	Other: observational cohort with plasma samples; plasma samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Publications and helpful links

General Publications

• 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): February 26, 2019
• Primary Completion (ANTICIPATED): September 10, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (ACTUAL): September 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 2018-A00429-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No