Examining retinal blood vessel changes in colorectal cancer patients receiving targeted therapy
Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.
This study is testing how a cancer treatment called Bevacizumab affects the tiny blood vessels in the eyes of patients with metastatic colorectal cancer to see if these changes relate to how well the treatment works and any side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Georges Francois Leclerc Academic / other |
| Drugs / interventions | BEVACIZUMAB |
| Locations | 2 sites (Dijon and 1 other locations) |
| Trial ID | NCT04952688 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the changes in retinal vascular density in patients with metastatic colorectal cancer who are starting first-line treatment with Bevacizumab, an anti-VEGF therapy. Using OCT-angiography, researchers will non-invasively quantify retinal microvascularization and analyze how these changes correlate with treatment response and toxicity. The study seeks to provide insights into systemic vascular changes associated with oncological treatments, which are not well-documented in existing literature.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are starting first-line treatment for metastatic colorectal cancer with Bevacizumab.
Not a fit: Patients with a history of eye diseases, diabetes, or those unable to undergo the required ophthalmological assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the systemic effects of anti-angiogenic therapy and improve monitoring of treatment responses in colorectal cancer patients.
How similar studies have performed: While there is limited literature on the specific relationship between retinal microvascular changes and anti-VEGF therapy in colorectal cancer, similar studies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient over 18 years old starting first-line treatment for metastatic colorectal cancer including BEVACIZUMAB (AVASTIN®) 2. Systemic or intraocular anti-VEGF treatment naïve 3. ECOG ≤ 2 Exclusion Criteria: 1. Pregnant woman, 2. Minor patient or under legal protection 3. Person deprived of liberty or under guardianship 4. Inability to undergo medical monitoring of the trial 5. Impossibility of carrying out the OCT-A 6. Patient with a contraindication to Tropicamide 0.5% eye drops 7. Patient with a history of degenerative macular pathology, vascular macular pathology or presenting an epiretinal membrane with traction phenomenon. 8. Diabetes 9. Patient for whom it is not possible to schedule an ophthalmology consultation before the start of treatment.
Where this trial is running
Dijon and 1 other locations
- Centre Georges François Leclerc — Dijon, France (Recruiting)
- CHU de Dijon — Dijon, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Audrey HENNEQUIN — Centre Georges François Leclerc
- Study coordinator: Audrey HENNEQUIN
- Email: ahennequin@cgfl.fr
- Phone: 03 80 73 75 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.