Cardiovascular Effects of Sunitinib Therapy (CREST)
Түлхүүр үгс
Хураангуй
Тодорхойлолт
Tyrosine kinase inhibitors such as sunitinib have dramatically improved the overall management of certaincancers including renal cell carcinoma. However, recent data suggest that these therapieshave significant off-target effects with cardiac toxicity, including significant hypertension and ventricular cardiac dysfunction being a major concern. However, the biologic mechanisms underlying cardiotoxicty in humans remain poorly defined. Moreover, there is a critical need to develop methods to improve the risk stratification and early identification of patients who will suffer from hypertension and cardiac dysfunction with exposure to therapy. The over all objectives ofthis study are to further characterize the cardiovascular changes that occur with sunitinib exposure in order to improve our understanding of sunitib toxicity and determine early, mechanistically and clinically relevant predictors to identify patients at increased risk of hyptertension and cardiac dysfunction. The specific aims of this study are: 1) To define the changes in arterial hemodynamics that may occur with exposure to sunitinib, 2) To define the changes in sensitive echocardiographic measures of cardiac function that may occur with exposure to sunitinib, 3) To determine blood markers that are associated with changes in vasculature or cardiac function with exposure to sunitinib. and 4) To determine if there are early imaging or biomarker predictors of subitinib cardiotoxicity.
Огноо
Сүүлд баталгаажуулсан: | 09/30/2018 |
Эхлээд оруулсан: | 05/25/2011 |
Тооцоолсон элсэлтийг оруулсан: | 06/07/2011 |
Эхлээд нийтэлсэн: | 06/08/2011 |
Сүүлийн шинэчлэлтийг оруулсан: | 09/30/2018 |
Сүүлийн шинэчлэлтийг нийтэлсэн: | 10/01/2018 |
Сургалтын бодит эхлэх огноо: | 03/31/2011 |
Тооцоолсон анхан шатны ажил дуусах огноо: | 12/30/2017 |
Судалгааны ажлыг дуусгах өдөр: | 12/30/2017 |
Нөхцөл байдал эсвэл өвчин
Үе шат
Arm Groups
Гар | Хөндлөнгийн оролцоо / эмчилгээ |
---|---|
Penn Site Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks, with additional follow-up at 1 and 2 years. | |
Vanderbilt University Medical Center Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. | |
Case Medical Center Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. | |
University of Wisconsin at Madison Patients with renal cell cancer newly undergoing therapy with the oral tyrosine kinase inhibitor sunitinib will be recrutied and observed over a period of approximately 33 weeks. |
Эрхийн шалгуур
Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
Суралцах боломжтой хүйс | All |
Дээж авах арга | Probability Sample |
Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
Шалгуур үзүүлэлтүүд | Inclusion Criteria: - Patients with renal cell carcinoma newly undergoing therapy with sunitinib. - Age greater than or equal to 18 years - ECOG performance status 0,1,2 Exclusion Criteria: - Any contraindication to sunitinib therapy of note, patients with prior cardiovascular history are not excluded from this study, as long as there are no contraindications to sunitinib therapy. |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Change from Baseline in Systolic Blood Pressure [6 Months]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Number of Participants with adverse events [2 years]