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出境医 / 临床实验 / Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer (AVOCETTE)
Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer (AVOCETTE)
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 |
|---|---|
| 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.
Study Design
| 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 |
Arms 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:
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Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Joachim Alexandre, MD, PhD | +33231064670 | alexandre-j@chu-caen.fr | |
| Contact: Charles Dolladille, MD | +33231064670 | dolladille-c@chu-caen.fr |
Locations
| France | |
| CHU Caen | |
| Caen, Normandy, France, 14000 | |
| Contact: Joachim Alexandre, MD +33231064670 alexandre-j@chu-caen.fr | |
Sponsors and Collaborators
University Hospital, Caen
Investigators
| Principal Investigator: | Joachim Alexandre, MD, PhD | CHu Caen |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | October 12, 2018 | ||||
| First Posted Date | April 22, 2019 | ||||
| Last Update Posted Date | April 22, 2019 | ||||
| Estimated Study Start Date | April 2019 | ||||
| Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer | ||||
| Official Title | Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry | ||||
| 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. | ||||
| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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). | ||||
| Condition | Colorectal Cancer Metastatic | ||||
| Intervention | 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:
|
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| Study Groups/Cohorts | 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) Intervention: Drug: Antineoplastic Agents
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
2000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 2019 | ||||
| Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03923036 | ||||
| Other Study ID Numbers | TPS 68479 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Caen | ||||
| Study Sponsor | University Hospital, Caen | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University Hospital, Caen | ||||
| Verification Date | October 2018 | ||||
