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.
Study Type
OBSERVATIONAL
Enrollment
200
Alpha Oncology Research LLC
DeBary, Florida, United States
COMPLETEDUniversity of Maryland School of Medicine
Baltimore, Maryland, United States
RECRUITINGJohns Hopkins University School of Medicine
Baltimore, Maryland, United States
NOT_YET_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
COMPLETEDWashington University Medical School
St Louis, Missouri, United States
COMPLETEDOhio State University
Columbus, Ohio, United States
COMPLETEDUniversity of Pensylvania Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Vermont Medical Center
Burlington, Vermont, United States
RECRUITINGVCU Medical Center
Richmond, Virginia, United States
RECRUITINGPercent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
Time frame: Through study completion, 2 years
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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