Interobserver Variability Desmoplasia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Presence of desmoplasia Tumors with presence of desmoplasia according to the predefined definition. |
Other: Assessment by dermatopathologists
Histological assessment of the cSCCs by eight dermatopathologists.
|
| Absence of desmoplasia Tumors in absence of desmoplasia according to the predefined definition. |
Other: Assessment by dermatopathologists
Histological assessment of the cSCCs by eight dermatopathologists.
|
Outcome Measures
Primary Outcome Measures
- Interobserver agreement [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 Outcome Measures
- Definitions used [Before the histological assessment, at baseline.]
A description of the different definitions of desmoplasia used by the dermatopathologists.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histological coupes of patients with a cSCC between 2010 and 2018 (both cSCC with and without desmoplasia are included)
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Treated at the Maastricht University Medical Center+ (MUMC+)in Maastricht for their cSCC
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Of which the histology is available in the MUMC+
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maastricht University Medical Center+ | Maastricht | Netherlands |
Sponsors and Collaborators
- Maastricht University Medical Center
Investigators
- Principal Investigator: K Mosterd, MD, PhD, Maastricht University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- 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.
- 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
- 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.
- 2023-3752