Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer (AVOCETTE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03923036|
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Metastatic||Drug: Antineoplastic Agents|
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|
|Estimated Enrollment :||2000 participants|
|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|
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.
- 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.
- 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.
- 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).
- 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
- 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.
- 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.
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
|Contact: Joachim Alexandre, MD, PhDemail@example.com|
|Contact: Charles Dolladille, MDfirstname.lastname@example.org|
|CHU Caen||Not yet recruiting|
|Caen, Normandy, France, 14000|
|Contact: Joachim Alexandre, MD +33231064670 email@example.com|
|Principal Investigator:||Joachim Alexandre, MD, PhD||CHu Caen|