Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03923036
Collaborator
(none)
2,000
Enrollment
1
Location
2
Anticipated Duration (Months)
998
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
Anticipated Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm 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:
  • fluorouracile
  • irinotecan
  • oxaliplatine
  • bevacizumab
  • aflibercept
  • capecitabine
  • cetuximab
  • panitumumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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).

    3. 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

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Caen Caen Normandy France 14000

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    • Principal Investigator: Joachim Alexandre, MD, PhD, CHu Caen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT03923036
    Other Study ID Numbers:
    • TPS 68479
    First Posted:
    Apr 22, 2019
    Last Update Posted:
    Apr 22, 2019
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Cetuximab
    Panitumumab
    Aflibercept
    Capecitabine
    Irinotecan
    Antineoplastic Agents

    Study Results

    No Results Posted as of Apr 22, 2019