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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Normandy
-
Caen、Normandy、フランス、14000
- CHU Caen
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Risk of cardiovascular adverse events (any) for each individual anticancer drug.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Between 2004 and 2017
|
Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.
|
Between 2004 and 2017
|
協力者と研究者
捜査官
- 主任研究者：Joachim Alexandre, MD, PhD、CHU Caen
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TPS 68479
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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