Ocular Blood Flow in Colorectal Cancer Patients

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02423785
• Other study ID #: OBF-13
• Status: Terminated
• Start date: May 2014
• Est. completion date: January 2022

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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