NCT05817149

Brief Summary

We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

June 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

April 5, 2023

Last Update Submit

April 5, 2023

Conditions

MelanomaSurgery

Keywords

MelanomaSurgeryNeutrophil-to-lymphocyte ratioSurgical inflammation

Outcome Measures

Primary Outcomes (1)

  • Neutrophil-to-lymphocyte ratio

    Ratio between neutrophil granulocytes and lymphocytes

    1 Day

Secondary Outcomes (2)

  • Pro-inflammatory cytokines

    1 Day

  • Acute phase reactants

    1 Day

Study Arms (1)

Patients with melanoma

Patients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples.

Procedure: Blood samples

Interventions

Blood samplesPROCEDURE

Blood samples

Patients with melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients (n=20) diagnosed with malignant melanoma and scheduled for SLNB at Aalborg University Hospital were consecutively included from June 2021 to October 2021.

You may qualify if:

  • Adult (\>18 years of age)
  • Diagnosed with invasive cutaneous melanoma
  • Eligible for SLNB (Melanoma stage ≥ T1b)
  • Obtained signed informed consent

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, The North Denmark Region, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Perioperative blood samples.

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d-student

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

June 22, 2021

Primary Completion

October 6, 2021

Study Completion

January 20, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

DK(1)