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NCT03909464 · ClinicalTrials.gov registry record

Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy

A clinical trial, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
26
Enrollment target

NCT03909464 is a clinical trial that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 26 participants.

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The verdict

NCT03909464 has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
26 participants
Enrollment target

Study Summary

Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the natural history of CIPN, and the early detection and quantification of CIPN is a significant challenge. Design: The investigators propose a cohort study to evaluate the performance of the Pressure-Specified Sensory Device TM (PSSD) in assessing CIPN associated with various common chemotherapy regimens. The proposed study will examine peripheral nerve function before, during, and after chemotherapy treatment. Peripheral neuropathy will be assessed using the PSSD, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN-20, and the Michigan Neuropathy Screening Instrument (MNSI). These are all established and validated methods to screen for a variety of conditions that cause peripheral neuropathy. Hypotheses: The investigators hypothesize that the PSSD will be a sensitive and specific tool for measuring CIPN. The onset of CIPN as detected by the PSSD will be compared with other screening modalities including the EORTC QLQ-CIPN20 and the MNSI. Importance: The development of CIPN often goes unnoticed until symptoms are bothersome. Having an objective tool in the care team's armament to screen for CIPN could have a significant public health impact.

Interventions

  • DEVICE Neurosensory testing with Pressure-Specified Sensory Device

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2017-11-29
Est. Completion 2019-11-25

What the Registry Record Tells You About NCT03909464

The ClinicalTrials.gov registry entry for NCT03909464 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Neurosensory testing with Pressure-Specified Sensory Device is the first listed.

NCT03909464 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03909464 about?

NCT03909464 is a clinical study titled "Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy". Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the ...

What is the current status of trial NCT03909464?

This trial is currently completed. The enrollment target is 26 participants. The study started on 2017-11-29. Estimated completion is 2019-11-25.

What interventions are being tested in trial NCT03909464?

The interventions under investigation include: Neurosensory testing with Pressure-Specified Sensory Device (DEVICE).

Who is sponsoring clinical trial NCT03909464?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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