Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma (BASIX)
Basal cell carcinoma (BCC) is the most frequent skin cancer in humans, primarily located in sun-exposed areas. The incidence of BCC increases with cumulative exposure to ultraviolet (UV) radiation and is particularly high in the elderly population, with a reported peak around 80 years of age. The new EADO classification distinguishes BCCs as 'easy-to-treat' and 'difficult-to-treat', subdivided into stages I-IV, with the aim of guiding therapeutic choices.
However, in clinical practice, there is marked variability among specialists in classification and treatment selection, with potential implications for clinical outcomes. This study aims to investigate inter-operator variability in both classification and therapeutic decisions for BCC. Specifically, it analyzes how specialists from different disciplines-dermatologists, oncologists, plastic surgeons, maxillofacial surgeons, and radiation therapists-and with varying clinical experience in BCC management approach the same clinical cases.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andrea Paradisi
- Phone Number: +390630155701
- Email: andrea.paradisi@policlinicogemelli.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The included case will consist of adult patients ≥ 18 years, with histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image (blurry, under/overexposed, wrong lesion will be excluded).
A total of 20 physicians from Policlinico Gemelli will be interviewed: 4 dermatologists, 4 plastic surgeons, 4 maxillofacial surgeons, 4 oncologists, and 4 radiotherapists.
Description
Inclusion Criteria:
- adult patients ≥ 18 years,
- histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image.
Inclusion criteria (physicians)
- Licensed medical doctors practicing in one of the target specialties: Dermatology, Plastic Surgery, Maxillofacial Surgery, Medical Oncology, or Radiotherapy.
- Currently involved in clinical management of BCC
- Able to provide informed consent for participation.
- Willing and able to complete the online questionnaire within the study timeframe.
- Minimum clinical experience: ≥ 1 year after specialty certification
Exclusion Criteria for patients:
- not diagnosed BCC cases
- patients <18 years
Exclusion Criteria for physicians:
- clinical experience <1 year after specialty certification
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter-operator variability in the BCC classification
Time Frame: 15 days
|
Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The impact of the therapeutic choices
Time Frame: 15 days
|
Examine if patient-related factors such as age, comorbidities, tumor site, tumor dimension and comorbidities may impact on the therapeutic choices across different specialties.
|
15 days
|
|
Evaluation of answers between different specialists
Time Frame: 15 days
|
Evaluate how specialists in the same field with different clinical background (dermatologists, oncologists, maxillofacial surgeons, radiotherapists, plastic surgeons ) and experience (low defined as 1-10 years -moderate:10-20-high: >20) on skin tumors answer the questionnaire
|
15 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrea Paradisi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27260
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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