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NCT03348956 · ClinicalTrials.gov registry record · NA
Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT03348956 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 7 participants.
The verdict
NCT03348956, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breast tumor will be assigned to receive an India ink injection under the skin of the foot. The ink will be used to make up to five (5) 45-minute "electron paramagnetic resonance" (EPR) oximetry readings prior to the start of chemotherapy. Subjects will undergo electrophysiologic assessments including nerve conduction studies, in addition to a neurological examination prior to the start of chemotherapy. Subjects will have the EPR oximetry readings, electrophysiologic tests, and neurological examination two more times: at the halfway point of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and again after chemotherapy has been completed. Subjects will also have blood drawn prior to beginning taxane-based chemotherapy, prior to every scheduled chemotherapy treatment, and after completion of chemotherapy in order to test for neurofilament light chain (NF-L).
Interventions
- DIAGNOSTIC_TEST EPR Oximetry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2022-02-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03348956
The ClinicalTrials.gov registry entry for NCT03348956 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which EPR Oximetry is the first listed.
NCT03348956 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03348956 about?
NCT03348956 is a clinical study titled "Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity". This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breas...
What is the current status of trial NCT03348956?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2018-03-01. Estimated completion is 2022-02-14.
What interventions are being tested in trial NCT03348956?
The interventions under investigation include: EPR Oximetry (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03348956?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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