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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: Antineoplastic Agents

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • CHU CAEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Exhaustive population of metastatic colorectal cancers in the French county Calvados registry diagnosed between 2004 and 2014 (synchrone and metachrone diagnosis).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Metastatic colorectal cancer; 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)

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.; Other Names: irinotecan; aflibercept; bevacizumab; capecitabine; cetuximab; panitumumab; fluorouracile; oxaliplatine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Joachim Alexandre, MD, PhD, CHU CAEN

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Irinotecan; Panitumumab; Cetuximab; Aflibercept; Antineoplastic Agents
• Other Study ID Numbers: TPS 68479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No