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Interobserver Variability Desmoplasia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06020612
Enrollment
50
Registered
2023-08-31
Start date
2023-07-01
Completion date
2024-06-01
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Squamous Cell Carcinoma, Metastasis, Pathology, Recurrence

Keywords

Interobserver variability, Interobserver agreement, Reproducibility, Dermatopathologist, Desmoplasia

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.

Interventions

OTHERAssessment by dermatopathologists

Histological assessment of the cSCCs by eight dermatopathologists.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Interobserver agreementThrough study completion, an average of 2 monthsInterobserver 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

MeasureTime frameDescription
Definitions usedBefore the histological assessment, at baseline.A description of the different definitions of desmoplasia used by the dermatopathologists.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026