Ocular Blood Flow in Colorectal Cancer Patients

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02423785

Enrollment

Registered

2015-04-22

Start date

2014-05-31

Completion date

2022-01-31

Last updated

2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)
Changes in retinal surface before and after therapy as measured by optical coherence tomography	Within 2-3 months at restaging	—

Countries

Austria

Outcome results