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This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alpha Oncology Research LLC
DeBary, Florida, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Medical School
St Louis, Missouri, United States
Ohio State University
Columbus, Ohio, United States
University of Pensylvania Hospital
Philadelphia, Pennsylvania, United States
University of Vermont Medical Center
Burlington, Vermont, United States
VCU Medical Center
Richmond, Virginia, United States
Start Date
July 3, 2019
Primary Completion Date
March 31, 2024
Completion Date
April 9, 2024
Last Updated
March 1, 2024
200
ESTIMATED participants
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559ClinicalTrials.gov@lilly.comLead Sponsor
Disarm Therapeutics
Collaborators
NCT07352514
NCT07064798
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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