An interventional study of Neurofilament light protein measurement in Isolated limb perfused patients in Malignant Melanoma, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Diagnostic
A prospective feasibility trial initially including 10 patients to investigate if Neurofilament light protein can be detected in peripheral blood in patients undergoing Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive biomarker for neurotoxicity after isolated limb perfusion.
In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of the fact that a relatively mild hyperthermic temperature is used which should be well tolerated by the nerves and other normal tissues in the limbs. It seems probable that the neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity combined with a local effect of a high tourniquet pressure that is used to isolate the blood flow. Prevention of regional and systemic toxicity is essential for improving the outcome after the procedure. It is known that both higher doses of melphalan, higher temperatures and longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading system for the reaction of the normal tissues after ILP and the grading is used as a routine in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid (CSF) during axonal damage and has been shown to be elevated in different forms of dementia. An NfL assay sensitive enough to measure NfL in blood was recently developed. Its concentration reflects axonal injury in both central and peripheral nervous system disorders.The primary aim of this study is to investigate the possibility to measure neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 18 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.
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Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.
Procedure: Neurofilament light protein measurement in Isolated limb perfused patients
A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Time frame: 1 day postoperatively
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Time frame: 3 days postoperatively
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Time frame: 4 weeks postoperatively
Plan to share: No
Ran from Apr 2019 to primary completion in Sep 2020, 17 months.
Of 196 non-industry interventional studies with no phase under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's 17 months is below that.
Counting every sponsor, half of 202 studies reached it within 39 months; a quarter within 21 and three quarters within 62.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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