Interobserver Variability Desmoplasia

Completed

• Conditions: Cutaneous Squamous Cell Carcinoma; Metastasis; Recurrence; Pathology
• Interventions: Other: Assessment by dermatopathologists

• Registration Number: NCT06020612
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

According to the most recent guideline of the National Comprehensive Cancer Network (NCCN), desmoplasia is considered to be a very high risk factor for recurrence, metastasis and death in cutaneous squamous cell carcinoma (cSCC). The presence of desmoplasia is assessed by dermatopathologists during histological examination of cSCCs. However, the inter-observer agreement is between dermatopathologists in the assessment of desmoplasia is unclear. Studies on inter-observer variability in the assessment of differentiation grade in cSCCs showed that there is only a weak to moderate agreement among dermatopathologists in the assessment of differentiation grade (2-4). This study aims to investigate the interobserver agreement of desmoplasia between dermatopathologists. In this prospective study, 50 cSCCs will be assessed for desmoplasia by at least eight dermatopathologists using a predefined definition.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-08-31
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histological coupes of patients with a cSCC between 2010 and 2018 (both cSCC with and without desmoplasia are included)
• Treated at the Maastricht University Medical Center+ (MUMC+)in Maastricht for their cSCC
• Of which the histology is available in the MUMC+

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Presence of desmoplasia	Assessment by dermatopathologists	Tumors with presence of desmoplasia according to the predefined definition.
Absence of desmoplasia	Assessment by dermatopathologists	Tumors in absence of desmoplasia according to the predefined definition.

Primary Outcome Measures

Name	Time	Method
Interobserver agreement	Through study completion, an average of 2 months	Interobserver agreement between dermatopathologists in the assessment of desmoplasia, expressed as percentages and Fleiss' kappa (Landis and Koch, see below) \<0 Poor agreement 0.0-0.20 Slight agreement 0.21-0.40 Fair agreement 0.41-0.60 Moderate agreement 0.61-0.80 Substantial agreement 0.81-1.00 Almost perfect agreement

Secondary Outcome Measures

Name	Time	Method
Definitions used	Before the histological assessment, at baseline.	A description of the different definitions of desmoplasia used by the dermatopathologists.

Trial Locations

Locations (1)

Maastricht University Medical Center+; 🇳🇱 Maastricht, Netherlands