Colorectal Cancer MetastaticAVOCETTENCT03923036
Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer
An observational study of Colorectal Cancer Metastatic, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Antineoplastic Agents
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2019to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exhaustive population of metastatic colorectal cancers in the French county Calvados registry diagnosed between 2004 and 2014 (synchrone and metachrone diagnosis).
Who may be able to join
- Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
Who cannot join
- Minors < 18 year old
- Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Caen
Caen, Normandy, 14000
Joachim Alexandre, MD, +33231064670, alexandre-j@chu-caen.fr
About this study
Official title: Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
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.
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Antineoplastic Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antineoplastic AgentsDrug
Also called fluorouracile, irinotecan, oxaliplatine, bevacizumab
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Antineoplastic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 2004 and 2017
Secondary outcomes (5)
Risk of cardiovascular adverse events (any) for each individual anticancer drug.
Drug exposure will be defined as a binary variable for each drug. (intakes/no intakes). A competing risk model will be used.
Measured: Between 2004 and 2017
Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol
Drugs combination will be defined as a binary variable for each protocol. (intakes/no intakes).
Measured: Between 2004 and 2017
Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients
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
Measured: Between 2004 and 2017
Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events
Dose will be approached by the number of cycles of the anticancer drug and by the cumulative dose (in milligram) received.
Measured: Between 2004 and 2017
Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events
Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.
Measured: Between 2004 and 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim Alexandre, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923036
- Sponsor's protocol ID
- TPS 68479
- Acronym
- AVOCETTE
- Status last verified
- Oct 2018
- First submitted
- 12 Oct 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
- ClinicalTrials.gov ID
- NCT03923036
- Acronym / sponsor ID
- AVOCETTE / TPS 68479
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic colorectal cancer | – | Drug: Antineoplastic AgentsThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exhaustive population of metastatic colorectal cancers in the French county Calvados registry diagnosed between 2004 and 2014 (synchrone and metachrone diagnosis).
Key inclusion criteria (1 listed)
- Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
Key exclusion criteria (2 listed)
- Minors < 18 year old
- Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antineoplastic AgentsAlso: fluorouracile, irinotecan, oxaliplatine, bevacizumabExposure 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. | Drug | Metastatic colorectal cancer |
Primary outcome
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.
5 secondary outcomes
Risk of cardiovascular adverse events (any) for each individual anticancer drug.
Time frame: Between 2004 and 2017
Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol
Time frame: Between 2004 and 2017
Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients
Time frame: Between 2004 and 2017
Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events
Time frame: Between 2004 and 2017
Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events
Time frame: Between 2004 and 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Alexandre, MD, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Alexandre, MD, PhD (+33231064670, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients. (time frame: Between 2004 and 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.