Clinical trial · Observational
Interobserver Variability Desmoplasia
Desmoplasia in Cutaneous Squamous Cell Carcinoma: Inter Observer Agreement Between Dermatopathologists.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Metastasis | — | UNRESOLVED | — |
| Pathology | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment by dermatopathologists | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Presence of desmoplasia
- description
- Tumors with presence of desmoplasia according to the predefined definition.
- interventionNames
- Other: Assessment by dermatopathologists
- label
- Absence of desmoplasia
- description
- Tumors in absence of desmoplasia according to the predefined definition.
- interventionNames
- Other: Assessment by dermatopathologists
Primary outcomes (1)
- measure
- Interobserver agreement
- timeFrame
- Through study completion, an average of 2 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDNational 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
- BACKGROUNDPrezzano 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
- BACKGROUNDFujimoto 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
- BACKGROUNDNash 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
- BACKGROUNDLandis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. PMID 843571