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Trial Title:
Interobserver Variability Desmoplasia
NCT ID:
NCT06020612
Condition:
Cutaneous Squamous Cell Carcinoma
Pathology
Recurrence
Metastasis
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Recurrence
Fibrosis
Conditions: Keywords:
Interobserver variability
Interobserver agreement
Reproducibility
Dermatopathologist
Desmoplasia
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Assessment by dermatopathologists
Description:
Histological assessment of the cSCCs by eight dermatopathologists.
Arm group label:
Absence of desmoplasia
Arm group label:
Presence of desmoplasia
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maastricht University Medical Center+
Address:
City:
Maastricht
Country:
Netherlands
Start date:
July 1, 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06020612
