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

• Sponsor: Aalborg University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05817149
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melanoma; Surgery	Procedure: Blood samples

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 Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study
• Actual Study Start Date: Jun 22, 2021
• Actual Primary Completion Date: Oct 6, 2021
• Actual Study Completion Date: Jan 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with melanoma Patients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples.	Procedure: Blood samples; Blood samples

Outcome Measures

Primary Outcome Measures

1. Neutrophil-to-lymphocyte ratio [1 Day]

   Ratio between neutrophil granulocytes and lymphocytes

Secondary Outcome Measures

1. 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

2. Acute phase reactants [1 Day]

   CRP, LDH

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University Hospital	Aalborg	The North Denmark Region	Denmark	9000

Sponsors and Collaborators

• Aalborg University Hospital
• Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karoline Assifuah Kristjansen, MD, Ph.d-student, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT05817149
• Other Study ID Numbers: 2021-050
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Karoline Assifuah Kristjansen, MD, Ph.d-student, Aalborg University Hospital: Melanoma; Surgery; Neutrophil-to-lymphocyte ratio; Surgical inflammation
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Apr 18, 2023