Clinical trial · Observational
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
NCT07638007CI-TRIAL-00114193TKIrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Chronic Myeloid Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ONTOLOGY_EXACT | 0.98 |
| Disease/Condition Name Cancer-related Cognitive Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Observational group I
- description
- TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
- label
- Observational group II
- description
- Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
Primary outcomes (1)
- measure
- Subjective cognitive performance
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.