Disease/Condition Name Cancer-related Cognitive DysfunctionTKINCT07638007
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
An observational study of Disease/Condition Name Cancer-related Cognitive Dysfunction and Chronic Lymphocytic Leukemia (CLL), run by University of Rochester NCORP Research Base at 1 site in United States.
Trial summary
This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease/Condition Name Cancer-related Cognitive Dysfunction, Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia, BCR-ABL1 Positive
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosis of CML or CLL scheduled to receive first dose of TKI therapy within 30 days or have received first dose of TKI within the previous 30 days, as well as cancer-free individuals.
Who may be able to join
- TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL
- TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days
- TKI RECIPIENTS: Participants must be ≥ 18 years of age
- TKI RECIPIENTS: Participants must be able to speak and read English
- TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be ≥ 18 years of age
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- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to speak and read English
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to understand and willing to sign an informed consent document
- CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant)
Who cannot join
- Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation
- Participants must have no history of TKI therapy
- Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL
- Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year
- Participants must have no history of head trauma with loss of consciousness within the year prior to consent
- Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning
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- Participants must have no psychiatric condition that led to hospitalization within the past year
- Participants must not be currently pregnant
- Participants must not be colorblind based on self-report
- Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester NCORP Research Base
Rochester, New York, 14642
Ashley Mack, 585 - 275 - 1361, URCC_24060@urmc.rochester.edu
Karen Mustian, PhD
About this study
This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.
Read the detailed description
PRIMARY OBJECTIVE:
- Characterize differences in subjective CRCI longitudinally among patients receiving TKIs for CML or CLL.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
GROUP II: Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
- Conditions
- Disease/Condition Name Cancer-related Cognitive Dysfunction, Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia, BCR-ABL1 Positive
- Medical subject headings
- Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational group I | TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study. | |
| Observational group II | Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cognitive performance
Will be assessed using the FACT-Cog. Will apply multilevel models to study data. Will include main effects of time, group, and the group X time interaction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start21 Nov 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease/Condition Name Cancer-related Cognitive DysfunctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester NCORP Research Base
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michelle Janelsins, PhD, MPH, University of Rochester NCORP Research Base
- Investigators
- Michelle Janelsins, PhD, Study chair, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638007
- Sponsor's protocol ID
- URCC-24060
- Other IDs
- UG1CA189961, R01CA287666, NCI-2025-04174, URCC-24060, URCC-24060, URCC-24060
- Acronym
- TKI
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07638007
- Acronym / sponsor ID
- TKI / URCC-24060
- Conditions
- Disease/Condition Name Cancer-related Cognitive Dysfunction, Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia, BCR-ABL1 Positive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Rochester NCORP Research BaseUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 10 Jun 2026 (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 examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.
Detailed description
PRIMARY OBJECTIVE:
- Characterize differences in subjective CRCI longitudinally among patients receiving TKIs for CML or CLL.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
GROUP II: Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational group I | – | –TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study. |
| Observational group II | – | –Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of CML or CLL scheduled to receive first dose of TKI therapy within 30 days or have received first dose of TKI within the previous 30 days, as well as cancer-free individuals.
Key inclusion criteria (9 listed)
- TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL
- TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days
- TKI RECIPIENTS: Participants must be ≥ 18 years of age
- TKI RECIPIENTS: Participants must be able to speak and read English
- TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document
Key exclusion criteria (10 listed)
- Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation
- Participants must have no history of TKI therapy
- Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL
- Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year
- Participants must have no history of head trauma with loss of consciousness within the year prior to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective cognitive performance
Time frame: 12 months
Will be assessed using the FACT-Cog. Will apply multilevel models to study data. Will include main effects of time, group, and the group X time interaction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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.
Michelle Janelsins, PhD study chair
University of Rochester NCORP Research Base
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 Disease/Condition Name Cancer-related Cognitive Dysfunction and Chronic Lymphocytic Leukemia (CLL), run by University of Rochester NCORP Research Base at 1 site in United States.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Jun 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Mack, MS (585-275-1090, URCC_24060@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective cognitive performance (time frame: 12 months). 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 10 Jun 2026.