Cancer-related Cognitive ImpairmentNCT05186948
Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
An observational study of Cancer-related Cognitive Impairment, run by Innodem Neurosciences at 1 site in Canada.
Trial summary
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer-related Cognitive Impairment
- What is being tested?
- Eye-Tracking
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 230 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2022to 20 Jan 2025
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Center-Cedar Cancer Center
Montreal, Quebec, H4A 3J1
About this study
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
Read the detailed description
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by the Cancer-related cognitive impairment (CRCI) and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of the Cancer-related cognitive impairment (CRCI) and associated cognitive changes.
- Conditions
- Cancer-related Cognitive Impairment
- Being tested
- Eye-Tracking
- Keywords
- Cancer-related cognitive impairment (CRCI), Eye Movement Biomarkers, Eye-tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-TrackingDevice
Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Eye-Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 36
Secondary outcomes (3)
Change from Baseline in The Controlled Oral Word Association Test (COWAT) scores at Month 36
The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds).
Measured: Baseline and Month 36
Change from Baseline in The Trail Making Test (TMT) Parts A & B scores at Month 36
The Trail Making Test (TMT) is a neuropsychological test that provides information on visual search, scanning, speed of processing, mental flexibility and executive functions. The TMT consists of two parts. TMT-A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-B except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task.
Measured: Baseline and Month 36
Change from Baseline in The Hopkins Verbal Learning Test-Revised (HVLT-R) scores at Month 36
The Hopkins Verbal Learning Test (HVLT-R) is a neuropsychological test that provides information on verbal learning and memory. The assessment consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall).
Measured: Baseline and Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start30 Mar 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Not enough personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Cognitive ImpairmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innodem Neurosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186948
- Sponsor's protocol ID
- ETNA-CRCI
- Status last verified
- Oct 2023
- First submitted
- 23 Dec 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
- ClinicalTrials.gov ID
- NCT05186948
- Acronym / sponsor ID
- ETNA-CRCI
- Conditions
- Cancer-related Cognitive Impairment
- Keywords
- Cancer-related cognitive impairment (CRCI), Eye Movement Biomarkers, Eye-tracking
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough personnel
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Innodem NeurosciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 11 Jan 2022 (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.
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
Detailed description
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by the Cancer-related cognitive impairment (CRCI) and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of the Cancer-related cognitive impairment (CRCI) and associated cognitive changes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients (stages I-IIIA) | – | Device: Eye-Tracking200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria |
| healthy control | – | Device: Eye-TrackingGroup of 30 healthy control participants, matched for age and sex, with no evidence or history of significant neurodegenerative disorder affecting brain function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- For all participants:
- For patients only:
Key exclusion criteria (9 listed)
- For all participants:
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 |
|---|---|---|
| Eye-TrackingEye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device. | Device | Breast cancer patients (stages I-IIIA), healthy control |
Primary outcome
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36
Time frame: Baseline and 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.
3 secondary outcomes
Change from Baseline in The Controlled Oral Word Association Test (COWAT) scores at Month 36
Time frame: Baseline and Month 36
Change from Baseline in The Trail Making Test (TMT) Parts A & B scores at Month 36
Time frame: Baseline and Month 36
Change from Baseline in The Hopkins Verbal Learning Test-Revised (HVLT-R) scores at Month 36
Time frame: Baseline and Month 36
Results and safety
The study was stopped early (reason given: Not enough personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Cognitive Impairment, run by Innodem Neurosciences at 1 site in Canada.
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 10 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: stopped early, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: Not enough personnel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36 (time frame: Baseline and Month 36). 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 6 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.