Interobserver Variability Desmoplasia

Study Overview
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Brief Summary
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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.

Official Title
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Desmoplasia in Cutaneous Squamous Cell Carcinoma: Inter Observer Agreement Between Dermatopathologists.

Conditions
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Cutaneous Squamous Cell Carcinoma, Pathology, Recurrence, Metastasis

Intervention / Treatment
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* Other: Assessment by dermatopathologists


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Presence of desmoplasia<br>Tumors with presence of desmoplasia according to the predefined definition. | Other: Assessment by dermatopathologists<br>* Histological assessment of the cSCCs by eight dermatopathologists.<br>|
| Absence of desmoplasia<br>Tumors in absence of desmoplasia according to the predefined definition. | Other: Assessment by dermatopathologists<br>* Histological assessment of the cSCCs by eight dermatopathologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interobserver agreement | 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 | Through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitions used | A description of the different definitions of desmoplasia used by the dermatopathologists. | Before the histological assessment, at baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interobserver variability, Interobserver agreement, Reproducibility, Dermatopathologist, Desmoplasia