Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study

Completed

• Conditions: Surgery; Melanoma
• Interventions: Procedure: Blood samples

• Registration Number: NCT05817149
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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

Detailed Description

Sentinel lymph node biopsy (SLBN) is essential in staging melanoma and properly selecting patients for adjuvant immunotherapy. However, surgically induced inflammation can potentially aid in progression of remaining malignant cells and affect prognosis. The inflammatory marker neutrophil-to-lymphocyte ratio (NLR) is also a negative prognostic and predictive marker in serval malignancies, among melanoma. However, it is not yet established if SLNB induces a systemic inflammatory response.

Study Timeline

• Study Start: 2021-06-22
• Primary Completion: 2021-10-06
• Study Completion: 2022-01-20
• Status Verified: 2023-04
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with melanoma	Blood samples	Patients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples.

Primary Outcome Measures

Name	Time	Method
Neutrophil-to-lymphocyte ratio	1 Day	Ratio between neutrophil granulocytes and lymphocytes

Secondary Outcome Measures

Name	Time	Method
Pro-inflammatory cytokines	1 Day	IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ
Acute phase reactants	1 Day	CRP, LDH

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, The North Denmark Region, Denmark