Interobserver Variability Desmoplasia

April 2, 2025 updated by: Maastricht University Medical Center

Desmoplasia in Cutaneous Squamous Cell Carcinoma: Inter Observer Agreement Between Dermatopathologists.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interobserver agreement
Time Frame: 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
Through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Definitions used
Time Frame: Before the histological assessment, at baseline.
A description of the different definitions of desmoplasia used by the dermatopathologists.
Before the histological assessment, at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: K Mosterd, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-3752

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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