Perioperative Examination of Inflammatory Markers in Rela... | NCT05817149

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

NCT05817149

Sponsor

Aalborg University Hospital

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Melanoma
Surgery

Interventions

Blood samples

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2021Actual

Primary Completion Date

Oct 6, 2021Actual

Completion Date

Jan 20, 2022Actual

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2023

Last Update Posted Date

Apr 18, 2023Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with melanoma		Patients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples.	Procedure: Blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Procedure	Blood samples	Patients with melanoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neutrophil-to-lymphocyte ratio	Ratio between neutrophil granulocytes and lymphocytes	1 Day

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients (n=20) diagnosed with malignant melanoma and scheduled for SLNB at Aalborg University Hospital were consecutively included from June 2021 to October 2021.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital		Aalborg	The North Denmark Region	9000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided