Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer (AVOCETTE)
19. april 2019 opdateret af: University Hospital, Caen
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Normandy
-
Caen, Normandy, Frankrig, 14000
- CHU Caen
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Exhaustive population of metastatic colorectal cancers in the French county Calvados registry diagnosed between 2004 and 2014 (synchrone and metachrone diagnosis).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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) |
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
Tidsramme: 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. |
Between 2004 and 2017
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk of cardiovascular adverse events (any) for each individual anticancer drug.
Tidsramme: 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.
|
Between 2004 and 2017
|
|
Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol
Tidsramme: Between 2004 and 2017
|
Drugs combination will be defined as a binary variable for each protocol.
(intakes/no intakes).
|
Between 2004 and 2017
|
|
Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients
Tidsramme: 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
|
Between 2004 and 2017
|
|
Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events
Tidsramme: 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.
|
Between 2004 and 2017
|
|
Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events
Tidsramme: Between 2004 and 2017
|
Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.
|
Between 2004 and 2017
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Joachim Alexandre, MD, PhD, CHU Caen
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. april 2019
Primær færdiggørelse (Forventet)
1. juni 2019
Studieafslutning (Forventet)
1. juni 2019
Datoer for studieregistrering
Først indsendt
12. oktober 2018
Først indsendt, der opfyldte QC-kriterier
19. april 2019
Først opslået (Faktiske)
22. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2019
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Topoisomerasehæmmere
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Topoisomerase I-hæmmere
- Capecitabin
- Irinotecan
- Panitumumab
- Cetuximab
- Aflibercept
- Antineoplastiske midler
Andre undersøgelses-id-numre
- TPS 68479
Plan for individuelle deltagerdata (IPD)
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