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

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Antineoplastic Agents

• Registration Number: NCT03923036
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-12
• Study Start: 2019-04
• Study First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Study First Posted: 2019-04-22
• Last Update Posted: 2019-04-22
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic colorectal cancer	Antineoplastic Agents	The French county Calvados registry of digestive cancers will allow to identify patients with a metastatic colorectal cancer diagnosed between 2004 and 2014. Patients will be included if the cancer was diagnosed at the metastatic stage between 2004 and 2014 or non-metastatic before 2004 that became metastatic between 2004 and 2014 (synchronous and metachronous tumors)

Primary Outcome Measures

Name	Time	Method
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.	Between 2004 and 2017	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.

Secondary Outcome Measures

Name	Time	Method
Risk of cardiovascular adverse events (any) for each individual anticancer drug.	Between 2004 and 2017	Drug exposure will be defined as a binary variable for each drug. (intakes/no intakes). A competing risk model will be used.
Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol	Between 2004 and 2017	Drugs combination will be defined as a binary variable for each protocol. (intakes/no intakes).
Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events	Between 2004 and 2017	Dose will be approached by the number of cycles of the anticancer drug and by the cumulative dose (in milligram) received.
Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events	Between 2004 and 2017	Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.
Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients	Between 2004 and 2017	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

Trial Locations

Locations (1)

CHU Caen; 🇫🇷 Caen, Normandy, France