NCT04460053

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

May 9, 2019

Last Update Submit

April 22, 2024

Conditions

Malignant Melanoma

Keywords

toxicitybiomarkerNeurofilament Light proteinIn-transit metastasisHyperthermic isolated limb perfusion

Outcome Measures

Primary Outcomes (3)

  • Neurofilament light protein measurement in peripheral blood

    Neurofilament light protein

    1 day postoperatively

  • Neurofilament light protein measurement in peripheral blood

    Neurofilament light protein

    3 days postoperatively

  • Neurofilament light protein measurement in peripheral blood

    Neurofilament light protein

    4 weeks postoperatively

Study Arms (1)

Neurofilament light protein measurement

EXPERIMENTAL

Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.

Procedure: Neurofilament light protein measurement in Isolated limb perfused patients

Interventions

Neurofilament light protein measurement in Isolated limb perfused patientsPROCEDURE

A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.

Neurofilament light protein measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for treatment with isolated limb perfusion
  • Age over 18 years
  • Signed informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (2)

  • Corderfeldt Keiller A, Axelsson M, Bragadottir G, Blennow K, Zetterberg H, Olofsson Bagge R. A prospective feasibility trial exploring novel biomarkers for neurotoxicity after isolated limb perfusion. Perfusion. 2024 Nov;39(8):1657-1666. doi: 10.1177/02676591231213506. Epub 2023 Nov 7.

    PMID: 37933726RESULT

  • Corderfeldt Keiller A, Holmen A, Hansson C, Ricksten SE, Bragadottir G, Olofsson Bagge R. Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion. Perfusion. 2023 Jul;38(5):1019-1028. doi: 10.1177/02676591221093201. Epub 2022 May 16.

    PMID: 35575302DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Roger Olofsson Bagge

    Sahlgrenska University Hospital, Department of Sugery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: A prospective feasibility trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 9, 2019

First Posted

July 7, 2020

Study Start

April 12, 2019

Primary Completion

September 18, 2020

Study Completion

October 25, 2020

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)