Clinical trial NCT06020612: Interobserver Variability Desmoplasia
Official title: Desmoplasia in Cutaneous Squamous Cell Carcinoma: Inter Observer Agreement Between Dermatopathologists.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Squamous Cell Carcinoma
Pathology
Recurrence
Metastasis
Keywords: Interobserver variability
Interobserver agreement
Reproducibility
Dermatopathologist
Desmoplasia
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Interobserver agreement
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: Definitions used
timeFrame: Before the histological assessment, at baseline.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
Study officials:
affiliation: Maastricht University Medical Center
name: K Mosterd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.