Back to resultsModifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer (VOCANGIO)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OCT- Angiographie
Sponsored by
About this trial
This is an interventional other trial for Colorectal Cancer focused on measuring retina, OCT-angiography, Anti-VEGF, microvascularization, Targeted therapy
Eligibility Criteria
Inclusion Criteria:
- Patient over 18 years old starting first-line treatment for metastatic colorectal cancer including BEVACIZUMAB (AVASTIN®)
- Systemic or intraocular anti-VEGF treatment naïve
- ECOG ≤ 2
Exclusion Criteria:
- Pregnant woman,
- Minor patient or under legal protection
- Person deprived of liberty or under guardianship
- Inability to undergo medical monitoring of the trial
- Impossibility of carrying out the OCT-A
- Patient with a contraindication to Tropicamide 0.5% eye drops
- Patient with a history of degenerative macular pathology, vascular macular pathology or presenting an epiretinal membrane with traction phenomenon.
- Diabetes
- Patient for whom it is not possible to schedule an ophthalmology consultation before the start of treatment.
Sites / Locations
- Centre Georges François LeclercRecruiting
- CHU de Dijon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Inclusion Before Anti-VEGF treatment: opht
Outcomes
Primary Outcome Measures
retinal vascular density retinal vascular density
this measurement will be the average of the 4 quadrants (temporal, nasal, superior and inferior 24). It will be performed by PLEX Elite 9000 Swept Source OCT-A before, during and at the end of the anti-angiogenic treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04952688
First Posted
June 18, 2021
Last Updated
July 2, 2021
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT04952688
Brief Title
Modifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer
Acronym
VOCANGIO
Official Title
Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
July 14, 2022 (Anticipated)
Study Completion Date
July 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
retina, OCT-angiography, Anti-VEGF, microvascularization, Targeted therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Inclusion
Before Anti-VEGF treatment: opht
Intervention Type
Other
Intervention Name(s)
OCT- Angiographie
Intervention Description
Ophthalmological examinations
Primary Outcome Measure Information:
Title
retinal vascular density retinal vascular density
Description
this measurement will be the average of the 4 quadrants (temporal, nasal, superior and inferior 24). It will be performed by PLEX Elite 9000 Swept Source OCT-A before, during and at the end of the anti-angiogenic treatment
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient over 18 years old starting first-line treatment for metastatic colorectal cancer including BEVACIZUMAB (AVASTIN®)
Systemic or intraocular anti-VEGF treatment naïve
ECOG ≤ 2
Exclusion Criteria:
Pregnant woman,
Minor patient or under legal protection
Person deprived of liberty or under guardianship
Inability to undergo medical monitoring of the trial
Impossibility of carrying out the OCT-A
Patient with a contraindication to Tropicamide 0.5% eye drops
Patient with a history of degenerative macular pathology, vascular macular pathology or presenting an epiretinal membrane with traction phenomenon.
Diabetes
Patient for whom it is not possible to schedule an ophthalmology consultation before the start of treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey HENNEQUIN
Phone
03 80 73 75 06
Email
ahennequin@cgfl.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey HENNEQUIN
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey HENNEQUIN
Phone
03 80 73 75 06
Email
ahennequin@cgfl.fr
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine DROUILLARD
Email
antoine.drouillard@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Modifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer
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