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Completed

NCT Number: NCT06020612

Interobserver Variability Desmoplasia

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.

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma Disease Attributes Fibrosis Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Pathology Recurrence

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center+

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment by dermatopathologists

Other

Histological assessment of the cSCCs by eight dermatopathologists.

Primary outcomes

  1. Interobserver agreement

    Time frame: 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 outcomes

  1. Definitions used

    Time frame: Before the histological assessment, at baseline.

    A description of the different definitions of desmoplasia used by the dermatopathologists.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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