Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)

NCT05186948 | Unknown

• 1 other identifier: ETNA-CRCI
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

Conditions

Cancer-related Cognitive Impairment

Keywords

Cancer-related cognitive impairment (CRCI); Eye Movement Biomarkers; Eye-tracking

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36

  The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.

  Baseline and Month 36

Secondary Outcomes (3)

• Change from Baseline in The Controlled Oral Word Association Test (COWAT) scores at Month 36

  Baseline and Month 36

• Change from Baseline in The Trail Making Test (TMT) Parts A & B scores at Month 36

  Baseline and Month 36

• Change from Baseline in The Hopkins Verbal Learning Test-Revised (HVLT-R) scores at Month 36

  Baseline and Month 36

Study Arms (2)

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

Device: Eye-Tracking

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.

Device: Eye-Tracking

Interventions

Eye-Tracking DEVICE

Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.

Breast cancer patients (stages I-IIIA); healthy control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data will be obtained from 200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria. Data will also be acquired from a group of 30 healthy control participants. Groups will be matched for age and sex.

You may qualify if:

• For all participants:
• Able to provide informed consent.
• Visual acuity sufficient to be able to read the consent form with corrective lenses.
• Over 18 years of age.
• English- or French-speaking.
• For patients only:
• Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy
• First-time cancer diagnosis.
• ECOG performance \< 2
• Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles

You may not qualify if:

• For all participants:
• Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.
• Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
• Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.
• Previous history of cancer or chemotherapy
• Distant metastases
• 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.
• Diagnosis of a substance abuse disorder.

Sponsors & Collaborators

• Innodem Neurosciences: lead

Study Sites (1)

McGill University Health Center-Cedar Cancer Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Interventions

Eye-Tracking Technology

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Marianna Perna

CONTACT

514-934-1934; marianna.perna@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: March 30, 2022
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

CA (1)