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临床试验/NCT02423785
NCT02423785终止不适用

Exploratory Study Investigating Ocular Blood Flow in Colorectal Cancer Patients Before and After Treatment With Anti-angiogenic Therapy

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thorsten Fuereder

Dr.med.

Medical University of Vienna

研究点 (1)

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