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Completed

NCT Number: NCT05817149

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

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, The North Denmark Region, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples

Procedure

Blood samples

Primary outcomes

  1. Neutrophil-to-lymphocyte ratio

    Time frame: 1 Day

    Ratio between neutrophil granulocytes and lymphocytes

Secondary outcomes

  1. Pro-inflammatory cytokines

    Time frame: 1 Day

    IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ

  2. Acute phase reactants

    Time frame: 1 Day

    CRP, LDH

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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