About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
not diagnosed BCC cases
patients <18 years
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Dermatological evaluation
Other interventionAdministration of three questionnaires to different groups of physicians to evaluate clinical staging and treatment decisions
Treatment groups
Trial outcomes
Primary outcomes
Inter-operator variability in the BCC classification
Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions
Secondary outcomes
The impact of the therapeutic choices
Examine if patient-related factors such as age, comorbidities, tumor site, tumor dimension and comorbidities may impact on the therapeutic choices across different specialties.
Evaluation of answers between different specialists
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
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: