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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05817149
Enrollment
20
Registered
2023-04-18
Start date
2021-06-22
Completion date
2022-01-20
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Surgery

Keywords

Melanoma, Surgery, Neutrophil-to-lymphocyte ratio, Surgical inflammation

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.

Interventions

PROCEDUREBlood samples

Blood samples

Sponsors

Aarhus University Hospital
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neutrophil-to-lymphocyte ratio1 DayRatio between neutrophil granulocytes and lymphocytes

Secondary

MeasureTime frameDescription
Pro-inflammatory cytokines1 DayIL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ
Acute phase reactants1 DayCRP, LDH

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026