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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Andrea Paradisi
- Telefoonnummer: +390630155701
- E-mail: andrea.paradisi@policlinicogemelli.it
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Inter-operator variability in the BCC classification
Tijdsspanne: 15 days
|
Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions
|
15 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The impact of the therapeutic choices
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Andrea Paradisi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studie record data
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Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 27260
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