Ocular Blood Flow in Colorectal Cancer Patients

April 23, 2022 updated by: Thorsten Fuereder, Medical University of Vienna

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

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients, who are treated at the Medical University of Vienna

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

April 19, 2015

First Posted (ESTIMATE)

April 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 23, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBF-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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