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

NCT03678337 | Unknown

• 1 other identifier: 2018-A00429-46
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardio-oncology

Outcome Measures

Primary Outcomes (1)

• Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up

  2 years

Secondary Outcomes (1)

• Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank

  2 years

Study Arms (1)

Observational cohort with plasma samples

Other: observational cohort with plasma samples

Interventions

observational cohort with plasma samples OTHER

plasma samples

Observational cohort with plasma samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen

Caen, Normandy, 14000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 31988143 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 19, 2018
• Study Start: February 26, 2019
• Primary Completion: September 10, 2020
• Study Completion: January 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)