Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

NCT07638007 | Recruiting

• 4 other identifiers: URCC-24060UG1CA189961R01CA287666NCI-2025-04174
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Disease/Condition Name Cancer-related Cognitive Dysfunction; Chronic Lymphocytic Leukemia (CLL); Chronic Myeloid Leukemia, BCR-ABL1 Positive

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

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.

Eligibility Criteria

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

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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester NCORP Research Base: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester NCORP Research Base

Rochester, New York, 14642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Study Officials

• Michelle Janelsins, PhD

  University of Rochester NCORP Research Base

  STUDY CHAIR

Central Study Contacts

Ashley Mack, MS

CONTACT

585-275-1090; URCC_24060@urmc.rochester.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: URCC Study Chair

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: June 10, 2026
• Study Start: November 21, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

US (1)