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

Cardio-oncology Clinical Trial

— PICARO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03678337
• Other study ID #: 2018-A00429-46
• Status: Recruiting
• Start date: February 26, 2019
• Est. completion date: January 2021

Study information

• Verified date: August 2018
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2021
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardio-oncology
• Drug-Related Side Effects and Adverse Reactions
• Neoplasms

Intervention

Other:
• observational cohort with plasma samples
plasma samples

Locations

Country	Name	City	State
France	CHU Caen	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up		2 years
Secondary	Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank		2 years