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

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ClinicalTrials.gov Identifier: NCT03923036
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colorectal Cancer Metastatic 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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Between 2004 and 2017 ]
    Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923036


Contacts
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Contact: Joachim Alexandre, MD, PhD +33231064670 alexandre-j@chu-caen.fr
Contact: Charles Dolladille, MD +33231064670 dolladille-c@chu-caen.fr

Locations
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France
CHU Caen Not yet recruiting
Caen, Normandy, France, 14000
Contact: Joachim Alexandre, MD    +33231064670    alexandre-j@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Joachim Alexandre, MD, PhD CHu Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03923036     History of Changes
Other Study ID Numbers: TPS 68479
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents