Modifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer

NCT ID: NCT04952688

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2025-12-14

Brief Summary

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Retinal microvascularization can provide important informations to systemic vascular phenomena. The non-invasive quantitative description of the retinal vascularization is now possible by performing OCT-angiography and their image analysis software (vascular density and retinal perfusion). Systemic microvacular changes during the establishment of oncological treatment by targeted antiangiogenic therapy are little described in the literature. The objective of this pilot study is to describe the evolution of the retinal vascular density of patients with antiangiogenic drugs. In addition, the evolution of the retinal vascular density of patients on antiangiogenic drugs will study as a function of the response to the treatment and the toxicity of these treatments.

Detailed Description

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The main objective of this study is to describe the change in retinal vascular density of patients with first-line colorectal cancer treated with Bevacizumab.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental

Inclusion

Before Anti-VEGF treatment: opht

Group Type EXPERIMENTAL

OCT- Angiographie

Intervention Type OTHER

Ophthalmological examinations

Interventions

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OCT- Angiographie

Ophthalmological examinations

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Georges Francois Leclerc

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Audrey HENNEQUIN

Role: PRINCIPAL_INVESTIGATOR

Centre Georges François Leclerc

Locations

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Centre Georges François Leclerc

Dijon, , France

Site Status RECRUITING

CHU de Dijon

Dijon, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Audrey HENNEQUIN

Role: CONTACT

03 80 73 75 06

Facility Contacts

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Audrey HENNEQUIN

Role: primary

03 80 73 75 06

Antoine DROUILLARD

Role: primary

Other Identifiers

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2020-A01178-31

Identifier Type: -

Identifier Source: org_study_id

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