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- Register voor klinische proeven in de VS.
- Klinische proef NCT07638007
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment (TKI)
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Ashley Mack, MS
- Telefoonnummer: 585-275-1090
- E-mail: URCC_24060@urmc.rochester.edu
Studie Locaties
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New York
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Rochester, New York, Verenigde Staten, 14642
- Werving
- University of Rochester NCORP Research Base
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Contact:
- Ashley Mack
- Telefoonnummer: 585 - 275 - 1361
- E-mail: URCC_24060@urmc.rochester.edu
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Hoofdonderzoeker:
- Karen Mustian, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
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Observational group I
TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Subjective cognitive performance
Tijdsspanne: 12 months
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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.
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12 months
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Michelle Janelsins, PhD, University of Rochester NCORP Research Base
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata
- Chronische ziekte
- Ziekte attributen
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Hematologische ziekten
- Lymfatische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Leukemie, B-cel
- Leukemie, myeloïde
- Beenmergziekten
- Leukemie, Lymfoïde
- Leukemie
- Myeloproliferatieve aandoeningen
- Pathologische aandoeningen, tekenen en symptomen
- Hemische en lymfatische ziekten
- Ziekte
- Leukemie, lymfatische, chronische, B-cel
- Leukemie, Myelogeen, Chronisch, BCR-ABL Positief
Andere studie-ID-nummers
- URCC-24060 (Andere identificatie: CTEP)
- UG1CA189961 (Subsidie/contract van de Amerikaanse NIH)
- R01CA287666 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2025-04174 (Register-ID: CTRP (Clinical Trial Reporting Program))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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