Prevention and Pharmacological Management of Cardiac Adverse Drug Reactions Induced by Drugs Used in Oncology. (PICARO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03678337|
Recruitment Status : Unknown
Verified August 2018 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : September 19, 2018
Last Update Posted : April 4, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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.
- 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.
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University Hospital, Caen|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Drug-Related Side Effects and Adverse Reactions