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NCT05817149 Clinical Trial

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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05817149
Other study ID # 2021-050
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2021
Est. completion date January 20, 2022

Study information
Verified date April 2023
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 20, 2022
Est. primary completion date October 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood samples
Blood samples

Locations
Country Name City State
Denmark Aalborg University Hospital Aalborg The North Denmark Region

Sponsors (2)
Lead Sponsor Collaborator
Aalborg University Hospital Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neutrophil-to-lymphocyte ratio Ratio between neutrophil granulocytes and lymphocytes 1 Day
Secondary Pro-inflammatory cytokines IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-a, and IFN-? 1 Day
Secondary Acute phase reactants CRP, LDH 1 Day
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