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Clinical trialNCT03997981UnknownObservational

Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

SponsorDisarm TherapeuticsEnrollment200Chemotherapy-induced Peripheral Neuropathy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    Study Director

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Alpha Oncology Research Llc

    DeBary, Florida, United States

    Completed
  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, United States

    Nina Wagner- Johnston
    Not, yet, recruiting
  • University of Maryland School of Medicine

    Baltimore, Maryland, United States

    Susan Dorsey, Ph.D, RN, FAAN
    Recruiting
  • University of Michigan

    Ann Arbor, Michigan, United States

    Ellen Smith, PhD, APRN, AOCN, FAAN
    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, United States

    Completed
  • Washington University Medical School

    St Louis, Missouri, United States

    Completed
  • Ohio State University

    Columbus, Ohio, United States

    Completed
  • University of Pensylvania Hospital

    Philadelphia, Pennsylvania, United States

    Chafic Karam
    Recruiting
  • University of Vermont Medical Center

    Burlington, Vermont, United States

    Noah Kolb, MD
    Recruiting
  • Vcu Medical Center

    Richmond, Virginia, United States

    Gordon Smith, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 Jul 2019
Primary completion
31 Mar 2024
Completion
9 Apr 2024
Last update posted
1 Mar 2024
Registered enrollment
200
Registry id
NCT03997981

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.