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

NCT03923036 | Unknown

• 1 other identifier: TPS 68479
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Risk of cardiovascular adverse events (any) for each individual anticancer drug.

  Between 2004 and 2017

• Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol

  Between 2004 and 2017

• Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients

  Between 2004 and 2017

• Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events

  Between 2004 and 2017

• Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events

  Between 2004 and 2017

Study Arms (1)

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

Interventions

Antineoplastic Agents DRUG

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.

Also known as: fluorouracile, irinotecan, oxaliplatine, bevacizumab, aflibercept, capecitabine, cetuximab, panitumumab

Metastatic colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Minors \< 18 year old
• Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen

Caen, Normandy, 14000, France

Location

MeSH Terms

Interventions

Antineoplastic Agents; Fluorouracil; Irinotecan; Oxaliplatin; Bevacizumab; aflibercept; Capecitabine; Cetuximab; Panitumumab

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Joachim Alexandre, MD, PhD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Alexandre, MD, PhD

CONTACT

+33231064670; alexandre-j@chu-caen.fr

Charles Dolladille, MD

CONTACT

+33231064670; dolladille-c@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: April 22, 2019
• Study Start: April 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 22, 2019

Record last verified: 2018-10

Locations

FR (1)