Interobserver Variability Desmoplasia

NCT ID: NCT06020612

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Squamous Cell Carcinoma Pathology Recurrence Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Presence of desmoplasia

Tumors with presence of desmoplasia according to the predefined definition.

Assessment by dermatopathologists

Intervention Type OTHER

Histological assessment of the cSCCs by eight dermatopathologists.

Absence of desmoplasia

Tumors in absence of desmoplasia according to the predefined definition.

Assessment by dermatopathologists

Intervention Type OTHER

Histological assessment of the cSCCs by eight dermatopathologists.

Interventions

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Assessment by dermatopathologists

Histological assessment of the cSCCs by eight dermatopathologists.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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K Mosterd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center+

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 34482328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31094931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34920027 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 843571 (View on PubMed)

Other Identifiers

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2023-3752

Identifier Type: -

Identifier Source: org_study_id

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