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

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ClinicalTrials.gov Identifier: NCT03678337
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date August 13, 2018
First Posted Date September 19, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date February 26, 2019
Estimated Primary Completion Date September 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2018)
Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2018)
Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology.
Official Title Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All cancer patients presenting the eligibility criteria referred to the PICARO program
Condition Cardio-oncology
Intervention Other: observational cohort with plasma samples
plasma samples
Study Groups/Cohorts Observational cohort with plasma samples
Intervention: Other: observational cohort with plasma samples
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). pii: e000261. doi: 10.1136/jitc-2019-000261.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date September 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03678337
Other Study ID Numbers 2018-A00429-46
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Caen
Study Sponsor University Hospital, Caen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Caen
Verification Date August 2018