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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

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
Cardio-oncology Other: observational cohort with plasma samples

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. The PICARO Cohort
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : September 10, 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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




Primary Outcome Measures :
  1. Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All cancer patients presenting the eligibility criteria referred to the PICARO program
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678337


Locations
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France
CHU Caen Recruiting
Caen, Normandy, France, 14000
Contact: Joachim Alexandre, MD    +33231064670    alexandre-j@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen

Additional Information:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03678337     History of Changes
Other Study ID Numbers: 2018-A00429-46
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Neoplasms
Chemically-Induced Disorders