Exploratory Study Investigating Ocular Blood Flow in Colorectal Cancer Patients Before and After Treatment With Anti-angiogenic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Changes in retinal surface before and after therapy as measured by optical coherence tomography
研究概览
简要总结
In colorectal cancer therapy anti-angiogenic strategies have become a cornerstone of treatment regimens in the metastatic setting. Addition of bevacizumab to conventional chemotherapeutic combination regimens has improved the median overall survival of advanced colorectal cancer patients by approximately 5 months. Selecting patients, who will benefit from anti-angiogenic approaches, would be highly desirable in order to optimize treatment strategies. Changes in ocular blood flow may be an attractive biomarker for predicting treatment response. In light of the given alternative first line treatment options such a predictive biomarker would be of clinical benefit. In the proposed study the investigators will assess potential changes in the ocular blood flow of mCRC patients after treatment with standard of care anti-angiogenic/cytotoxic therapy as an early predictive marker of treatment response as assessed by standard CT-scan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients (age 18 and over) suffering from mCRC.
- •Normal findings in ophthalmic examination (except the investigator finds an abnormality irrelevant for the purpose of the study.)
- •Patients, which are scheduled for standard of care treatment with chemotherapy plus bevacizumab
排除标准
- •Refusal to give informed consent
- •Severe hypertension (RR ≥180/110)
- •Pregnancy and breastfeeding women
结局指标
主要结局
Changes in retinal surface before and after therapy as measured by optical coherence tomography
时间窗: Within 2-3 months at restaging
Correlation between ocular blood flow (retinal blood flow) and treatment response
时间窗: Within 2-3 months at restaging
mean RBCs velocity in Hz and blood flow in arbitrary units will be reported and correlated with response rates (CR,PR,SD or PD)
Correlation between retinal vessel diameter and treatment response
时间窗: Within 2-3 months at restaging
Retinal vessel diameter will be reported and correlated with response rates (CR,PR,SD or PD)
次要结局
未报告次要终点
研究者
Thorsten Fuereder
Dr.med.
Medical University of Vienna
