Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
NCT ID: NCT05186948
Last Updated: 2023-10-18
Study Results
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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UNKNOWN
230 participants
OBSERVATIONAL
2022-03-30
2025-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Breast cancer patients (stages I-IIIA)
200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria
Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
healthy control
Group of 30 healthy control participants, matched for age and sex, with no evidence or history of significant neurodegenerative disorder affecting brain function.
Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
Interventions
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Eye-Tracking
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
Eligibility Criteria
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Inclusion Criteria
1. Able to provide informed consent.
2. Visual acuity sufficient to be able to read the consent form with corrective lenses.
3. Over 18 years of age.
4. English- or French-speaking.
* For patients only:
1. Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy
2. First-time cancer diagnosis.
3. ECOG performance \< 2
4. Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles
Exclusion Criteria
1. Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.
2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
3. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.
4. Previous history of cancer or chemotherapy
5. Distant metastases
6. Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.
7. Diagnosis of a substance abuse disorder.
8. Recreational drug use (e.g., alcohol, marijuana) is a potential exclusion criterion that will be determined on an individual basis as per the discretion of the research team. All recreational drug use will be documented.
18 Years
FEMALE
Yes
Sponsors
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Innodem Neurosciences
INDUSTRY
Responsible Party
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Locations
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McGill University Health Center-Cedar Cancer Center
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ETNA-CRCI
Identifier Type: -
Identifier Source: org_study_id
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