Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer (AVOCETTE)
Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
Normandy
-
Caen, Normandy, 프랑스, 14000
- CHU Caen
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Risk of cardiovascular adverse events (any) for each individual anticancer drug.
기간: 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
기간: 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
기간: 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
기간: 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
기간: Between 2004 and 2017
|
Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.
|
Between 2004 and 2017
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Joachim Alexandre, MD, PhD, CHU Caen
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TPS 68479
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .