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
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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|
|Observational cohort with plasma samples||
Other: observational cohort with plasma samples
- Number of Participants With AntiCancer Drugs-Related Cardiac Adverse Events during the follow-up [ Time Frame: 2 years ]
- Plasmatic tests to predict anticancer drugs-related cardiac adverse events from the constitution of the plasma biobank [ Time Frame: 2 years ]
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
|Caen, Normandy, France, 14000|
|Contact: Joachim Alexandre, MD +33231064670 email@example.com|