Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors (HARBOR)
HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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Amsterdam, Holandia, 1066 CX
- Rekrutacyjny
- NKI-AVL
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Groningen, Holandia, 9713 GZ
- Rekrutacyjny
- UMCG
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Przekrojowe
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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.
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Inne nazwy:
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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.
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Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Left ventricular ejection fraction
Ramy czasowe: up to 12 years after breast cancer diagnosis
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The main study parameter will be the difference in left ventricular ejection fraction between patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Diastolic cardiac function
Ramy czasowe: up to 12 years after breast cancer diagnosis
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To compare diastolic cardiac function as measured by tissue doppler echocardiography (E/e' and E/A ratio) in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Cardiac deformation
Ramy czasowe: up to 12 years after breast cancer diagnosis
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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.
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up to 12 years after breast cancer diagnosis
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Biomarker assessment
Ramy czasowe: up to 12 years after breast cancer diagnosis
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To compare levels of several (candidate) cardiovascular biomarkers (NT-proBNP, hs-TnT, CRP) in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Intima media thickness and arterial stiffness
Ramy czasowe: up to 12 years after breast cancer diagnosis
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To compare intima media thcikness and arterial stiffness as measured by vascular ultrasound in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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.
Ramy czasowe: up to 14 years after breast cancer diagnosis
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To compare each outcome of the first and second assessment separately in 1) every patient and 2) between patients treated with and without anthracyclines.
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up to 14 years after breast cancer diagnosis
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Flora E. van Leeuwen, Prof. dr., The Netherlands Cancer Institute
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NL49405.031.14
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