Malignant MelanomaILP-NfLNCT04460053
Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
A study testing Neurofilament light protein measurement in Isolated limb perfused patients in people with Malignant Melanoma, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Neurofilament light protein measurement in Isolated limb perfused patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 12 Apr 2019to 25 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for treatment with isolated limb perfusion
- Age over 18 years
- Signed informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
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.
Read the detailed description
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.
- Conditions
- Malignant Melanoma
- Being tested
- Neurofilament light protein measurement in Isolated limb perfused patients
- Keywords
- toxicity, biomarker, Neurofilament Light protein, In-transit metastasis, Hyperthermic isolated limb perfusion
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofilament light protein measurement in Isolated limb perfused patientsProcedure or surgery
A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.
| Study group | Role | What they receive |
|---|---|---|
| Neurofilament light protein measurement | Experimental | Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively. Receives: Procedure: Neurofilament light protein measurement in Isolated limb perfused patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Measured: 1 day postoperatively
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Measured: 3 days postoperatively
Neurofilament light protein measurement in peripheral blood
Neurofilament light protein
Measured: 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start12 Apr 2019
- Primary completion18 Sep 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective feasibility trial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Vastra Gotaland Region
- Investigators
- Roger Olofsson Bagge, Principal investigator, Sahlgrenska University Hospital, Department of Sugery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460053
- Sponsor's protocol ID
- ILP-NfL
- Acronym
- ILP-NfL
- Status last verified
- Apr 2024
- First submitted
- 9 May 2019
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37933726Corderfeldt 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.
PubMed 35575302
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
- ClinicalTrials.gov ID
- NCT04460053
- Acronym / sponsor ID
- ILP-NfL / ILP-NfL
- Conditions
- Malignant Melanoma
- Keywords
- toxicity, biomarker, Neurofilament Light protein, In-transit metastasis, Hyperthermic isolated limb perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Neurofilament light protein measurement | Experimental | Procedure: Neurofilament light protein measurement in Isolated limb perfused patientsNeurofilament light protein measurements in peripheral blood pre- peri- and postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for treatment with isolated limb perfusion
- Age over 18 years
- Signed informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofilament light protein measurement in Isolated limb perfused patientsA prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion. | Procedure or surgery | Neurofilament light protein measurement |
Primary outcome
Neurofilament light protein measurement in peripheral blood
Time frame: 1 day postoperatively
Neurofilament light protein
Neurofilament light protein measurement in peripheral blood
Time frame: 3 days postoperatively
Neurofilament light protein
Neurofilament light protein measurement in peripheral blood
Time frame: 4 weeks postoperatively
Neurofilament light protein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Results publication: PubMed 37933726Corderfeldt 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.
- Derived from this study: PubMed 35575302Corderfeldt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Olofsson Bagge principal investigator
Sahlgrenska University Hospital, Department of Sugery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofilament light protein measurement in Isolated limb perfused patients in people with Malignant Melanoma, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofilament light protein measurement in peripheral blood (time frame: 1 day postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.