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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Andrea Paradisi
- Telefonnummer: +390630155701
- E-mail: andrea.paradisi@policlinicogemelli.it
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Inter-operator variability in the BCC classification
Tidsramme: 15 days
|
Assess the inter-operator variability in BCC classification (EADO staging system) for the treatment decisions
|
15 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The impact of the therapeutic choices
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Andrea Paradisi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 27260
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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