Colorectal CancerVOCANGIONCT04952688
Modifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer
A study testing OCT- Angiographie in people with Colorectal Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- OCT- Angiographie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Dec 2020to 14 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre Georges François Leclerc
Dijon, 21000
Audrey HENNEQUIN, 03 80 73 75 06, ahennequin@cgfl.fr
- Not yet recruiting
CHU de Dijon
Dijon, 21000
Antoine DROUILLARD, antoine.drouillard@chu-dijon.fr
About this study
Official title: Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- OCT- Angiographie
- Keywords
- retina, OCT-angiography, Anti-VEGF, microvascularization, Targeted therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT- AngiographieOther
Ophthalmological examinations
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Inclusion
Before Anti-VEGF treatment: opht Receives: Other: OCT- Angiographie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start14 Dec 2020
- Primary completion14 Dec 2025 (estimated)
- Study completion14 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey HENNEQUIN, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952688
- Sponsor's protocol ID
- 2020-A01178-31
- Acronym
- VOCANGIO
- Status last verified
- Feb 2024
- First submitted
- 18 Jun 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.
- ClinicalTrials.gov ID
- NCT04952688
- Acronym / sponsor ID
- VOCANGIO / 2020-A01178-31
- Conditions
- Colorectal Cancer
- Keywords
- retina, OCT-angiography, Anti-VEGF, microvascularization, Targeted therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 14 Dec 2025 (estimated)
- Study completion
- 14 Dec 2025 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: OCT- AngiographieInclusion Before Anti-VEGF treatment: opht |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT- AngiographieOphthalmological examinations | Other | Experimental |
Primary outcome
retinal vascular density retinal vascular density
Time frame: 12 month
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey HENNEQUIN principal investigator
Centre Georges François Leclerc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT- Angiographie in people with Colorectal Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey HENNEQUIN (03 80 73 75 06, ahennequin@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal vascular density retinal vascular density (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.