NCT07638007RecruitingNot Applicable
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
University of Rochester NCORP Research Base1 site in 1 country400 target enrollmentStarted: November 21, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
PRIMARY OBJECTIVE:
I. 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
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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)
Exclusion Criteria
- •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
- •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)
Investigators
Michelle Janelsins, PhD, MPH
URCC Study Chair
University of Rochester NCORP Research Base
Study Sites (1)
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