Ocular Blood Flow in Colorectal Cancer Patients

Terminated

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT02423785
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2015-04-19
• Study First Posted: 2015-04-22
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-23
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• 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

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Exclusion Criteria

• Refusal to give informed consent
• Severe hypertension (RR ≥180/110)
• Epilepsy
• Pregnancy and breastfeeding women

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in retinal surface before and after therapy as measured by optical coherence tomography	Within 2-3 months at restaging
Correlation between ocular blood flow (retinal blood flow) and treatment response	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	Within 2-3 months at restaging	Retinal vessel diameter will be reported and correlated with response rates (CR,PR,SD or PD)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria