NCT07638007 Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
| NCT ID | NCT07638007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester NCORP Research Base |
| Condition | Disease/Condition Name Cancer-related Cognitive Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-11-21 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Michelle Janelsins, PhD
STUDY CHAIR
University of Rochester NCORP Research Base
Frequently Asked Questions
Who can join the NCT07638007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disease/Condition Name Cancer-related Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07638007 currently recruiting?
Yes, NCT07638007 is actively recruiting participants. Contact the research team at URCC_24060@urmc.rochester.edu for enrollment information.
Where is the NCT07638007 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07638007 clinical trial?
NCT07638007 is sponsored by University of Rochester NCORP Research Base. The principal investigator is Michelle Janelsins, PhD at University of Rochester NCORP Research Base. The trial plans to enroll 400 participants.
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