Interobserver Variability Desmoplasia

NCT06020612 | Completed

• 1 other identifier: 2023-3752
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Squamous Cell Carcinoma; Pathology; Recurrence; Metastasis

Keywords

Interobserver variability; Interobserver agreement; Reproducibility; Dermatopathologist; Desmoplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Definitions used

  Before the histological assessment, at baseline.

Study Arms (2)

Presence of desmoplasia

Tumors with presence of desmoplasia according to the predefined definition.

Other: Assessment by dermatopathologists

Absence of desmoplasia

Tumors in absence of desmoplasia according to the predefined definition.

Other: Assessment by dermatopathologists

Interventions

Assessment by dermatopathologists OTHER

Histological assessment of the cSCCs by eight dermatopathologists.

Absence of desmoplasia; Presence of desmoplasia

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients, both male and female, who were treated at MUMC+ between 2010 and 2018 for a cSCC, with and without desmoplasia, and whose histology is available.

You may qualify if:

• 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+

You may not qualify if:

• \- None

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Related Publications (5)

• National Comprehensive Cancer Network. Squamous Cell Skin Cancer (Version 2.2022) May 2, 2022. Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf

  BACKGROUND

• Prezzano JC, Scott GA, Lambert Smith F, Mannava KA, Ibrahim SF. Concordance of Squamous Cell Carcinoma Histologic Grading Among Dermatopathologists and Mohs Surgeons. Dermatol Surg. 2021 Nov 1;47(11):1433-1437. doi: 10.1097/DSS.0000000000003213.

  PMID: 34482328 BACKGROUND

• Fujimoto M, Yamamoto Y, Takai T, Fujimoto N, Ogawa K, Yoshikawa T, Matsuzaki I, Takahashi Y, Iwahashi Y, Warigaya K, Kojima F, Jinnin M, Murata SI. Tumor Budding Is an Objective High-risk Factor Associated With Metastasis and Poor Clinical Prognosis in Cutaneous Squamous Cell Carcinoma Sized <4 cm. Am J Surg Pathol. 2019 Jul;43(7):975-983. doi: 10.1097/PAS.0000000000001284.

  PMID: 31094931 BACKGROUND

• Nash J, Shahwan KT, Chung C, Abidi N, Gokun Y, Pan X, Carr DR. Grading of differentiation in cutaneous squamous cell carcinoma: Evaluation of interrater and intrarater reliability. J Am Acad Dermatol. 2022 Oct;87(4):895-897. doi: 10.1016/j.jaad.2021.12.015. Epub 2021 Dec 15. No abstract available.

  PMID: 34920027 BACKGROUND

• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

  PMID: 843571 BACKGROUND

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis; Fibrosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Study Officials

• K Mosterd, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 31, 2023
• Study Start: July 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

NL (1)