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| ID | Type | Description | Link |
|---|---|---|---|
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| R01CA287666 | U.S. NIH Grant/Contract | View source | |
| NCI-2025-04174 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC-24060 | Other Identifier | University of Rochester | |
| URCC-24060 | Other Identifier | DCP | |
| URCC-24060 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Mack, MS | Contact | 585-275-1090 | URCC_24060@urmc.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Janelsins, PhD | University of Rochester NCORP Research Base | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester NCORP Research Base | Recruiting | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
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Saliva
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |