Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

— AVOCETTE  

Official title:

Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03923036
• Other study ID #: TPS 68479
• Status: Not yet recruiting
• Start date: April 2019
• Est. completion date: June 2019

Study information

• Verified date: October 2018
• Source: University Hospital, Caen
• Contact: Joachim Alexandre, MD, PhD
• Phone: +33231064670
• Email: alexandre-j[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.

Description:

This study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. Descriptive analysis will include incidence, type of cardiovascular adverse events.

We will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. This will provide information about the individual drug safety profiles.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

Exclusion Criteria:

• Minors < 18 year old

• Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Antineoplastic Agents
Exposure measurement to any anticancer drug in its therapeutic use for the metastatic colorectal cancer with its posology and duration (the list provided is non-limitative). Exposure to anticancer drugs for another indication than the colorectal cancer will also be collected.

Locations

Country	Name	City	State
France	CHU Caen	Caen	Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.	Any cardiovascular adverse event (e.g. the non limitative list: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders) that was the primary diagnosis of a hospital admission.; Any anticancer drug (chemotherapy) intake will be considered for the primary analysis.; We will use a competing risk statistical model.	Between 2004 and 2017
Secondary	Risk of cardiovascular adverse events (any) for each individual anticancer drug.	Drug exposure will be defined as a binary variable for each drug. (intakes/no intakes). A competing risk model will be used.	Between 2004 and 2017
Secondary	Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol	Drugs combination will be defined as a binary variable for each protocol. (intakes/no intakes).	Between 2004 and 2017
Secondary	Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients	Several individual cardiovascular adverse events will be assessed in separate analyses: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders). A competing risk model will be used	Between 2004 and 2017
Secondary	Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events	Dose will be approached by the number of cycles of the anticancer drug and by the cumulative dose (in milligram) received.	Between 2004 and 2017
Secondary	Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events	Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.	Between 2004 and 2017