Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors (HARBOR)
HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
調査の概要
詳細な説明
Rationale: Breast cancer (BC) incidence is increasing, while mortality from BC is decreasing. Since the life expectancy of BC patients is improving, the evaluation of treatment-associated cardiovascular disease (CVD) in BC survivors is becoming increasingly important. An excess risk of CVD, mainly due to coronary heart disease (CHD), has been observed after radiotherapy (RT) as administered in the 1960s-1980s. Anthracycline-containing CT and trastuzumab are known to induce cardiotoxicity, especially congestive heart failure (CHF). However, the long-term risks of CVD after anthracycline-containing CT, trastuzumab, hormonal therapy (HT) and contemporary RT techniques have hardly been examined. Furthermore, the potential interaction of these treatment modalities has not been well addressed, and there is limited knowledge about the contribution of classic cardiovascular risk factors and the metabolic syndrome to risk and severity of treatment-associated CVD in BC survivors.
Objectives: • to evaluate the prevalence of (sub)clinical CVD, cardiovascular risk factors and metabolic abnormalities among BC survivors treated with and without anthracyclines in two groups at (a) 5 - 7 years and (b) 10 - 12 years after diagnosis;
• to prospectively evaluate changes in prevalence of (sub)clinical CVD, cardiovascular risk factors and metabolic abnormalities after two years in the same patients.
Secondary objectives are to evaluate the predictive role of newly developed markers for CVD and to evaluate the effects of other BC treatment modalities, psychosocial outcomes, endocrine function and menopausal status on the risk of developing (sub)clinical CVD.
Study design: multicenter (AVL and UMCG) cross-sectional cohort study with prospective monitoring of the same cohort.
Study population: female BC survivors treated with and without anthracyclines 5 - 7 and 10 - 12 years ago at the AVL or UMCG, aged 40-50 years at time of therapy.
Main study parameter: the difference in (sub)clinical cardiovascular damage between patients treated with and without anthracyclines, as measured by left ventricular function parameters.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Amsterdam、オランダ、1066 CX
- 募集
- NKI-AVL
-
Groningen、オランダ、9713 GZ
- 募集
- UMCG
-
-
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:
- early invasive BC (TNM stage I - III);
- diagnosed and/or treated in the AVL or UMCG;
- treated 5 - 7 years or 10 - 12 years ago;
- aged 40-50 years at time of therapy;
- signed written informed consent.
Exclusion Criteria:
- history of RT or CT unrelated to BC;
- current treatment for BC recurrence or second malignancy (including contralateral BC) with the exception of non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix;
- history of cardiac disease (CHF, acute coronary syndrome, coronary revascularization procedure, symptomatic valvular dysfunction, cardiomyopathy or congenital heart defect) before diagnosis and treatment for BC;
- mental disability or psychological condition potentially hampering compliance with the study protocol;
- insufficient understanding of the Dutch language.
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
- 観測モデル：コホート
- 時間の展望：断面図
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Anthracycline treated BC patients
AVL or UMCG patients between the age of 40 - 50 at the time of BC diagnosis and treatment, treated with anthracyclines respectively 5-7 years ago and 10-12 years ago.
|
他の名前：
|
|
Anthracycline naive BC patients
AVL or UMCG patients between the age of 40 - 50 at the time of BC diagnosis and treatment, treated without anthracyclines respectively 5-7 years ago and 10-12 years ago.
|
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 |
|---|---|---|
|
Left ventricular ejection fraction
時間枠：up to 12 years after breast cancer diagnosis
|
The main study parameter will be the difference in left ventricular ejection fraction between patients treated with and without anthracyclines.
|
up to 12 years after breast cancer diagnosis
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diastolic cardiac function
時間枠：up to 12 years after breast cancer diagnosis
|
To compare diastolic cardiac function as measured by tissue doppler echocardiography (E/e' and E/A ratio) in patients treated with and without anthracyclines.
|
up to 12 years after breast cancer diagnosis
|
|
Cardiac deformation
時間枠：up to 12 years after breast cancer diagnosis
|
To compare cardiac deformation as measured by speckle tracking imaging (global longitudial strain, radial strain and circumferential strain) in patients treated with and without anthracyclines.
|
up to 12 years after breast cancer diagnosis
|
|
Biomarker assessment
時間枠：up to 12 years after breast cancer diagnosis
|
To compare levels of several (candidate) cardiovascular biomarkers (NT-proBNP, hs-TnT, CRP) in patients treated with and without anthracyclines.
|
up to 12 years after breast cancer diagnosis
|
|
Intima media thickness and arterial stiffness
時間枠：up to 12 years after breast cancer diagnosis
|
To compare intima media thcikness and arterial stiffness as measured by vascular ultrasound in patients treated with and without anthracyclines.
|
up to 12 years after breast cancer diagnosis
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prospective evaluation of changes in LVEF, diastolic cardiac function, cardiac deformation, biomarkers levels, intima media thickness and arterial stiffness after two years in the same patients.
時間枠：up to 14 years after breast cancer diagnosis
|
To compare each outcome of the first and second assessment separately in 1) every patient and 2) between patients treated with and without anthracyclines.
|
up to 14 years after breast cancer diagnosis
|
協力者と研究者
捜査官
- 主任研究者：Flora E. van Leeuwen, Prof. dr.、The Netherlands Cancer Institute
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。