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

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03678337
Collaborator
(none)
200
1
22.2
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: observational cohort with plasma samples

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort
Actual Study Start Date :
Feb 26, 2019
Anticipated Primary Completion Date :
Sep 10, 2020
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Observational cohort with plasma samples

Other: observational cohort with plasma samples
plasma samples

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up [2 years]

Secondary Outcome Measures

  1. Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Caen Caen Normandy France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT03678337
Other Study ID Numbers:
  • 2018-A00429-46
First Posted:
Sep 19, 2018
Last Update Posted:
Apr 4, 2019
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2019